Trial Outcomes & Findings for A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement (NCT NCT04543188)
NCT ID: NCT04543188
Last Updated: 2025-10-23
Results Overview
DLT was defined as any adverse event (AE) or abnormal laboratory value which were related to study treatment and assessed as unrelated to disease (disease progression), occurring during the first 21 days of treatment that met at least 1 of the study specified criteria. DLTs were graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), version (v) 5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
65 participants
Primary outcome timeframe
Cycle 1 (21 Days)
Results posted on
2025-10-23
Participant Flow
The study consisted of 2 phases: Phase 1a (dose escalation, divided into monotherapy \[PF-07284890 alone\] and combination therapy \[PF-07284890 plus binimetinib\]) and Phase 1b (dose expansion).
A total of 65 participants were enrolled in the study: Phase 1a: 48 participants (monotherapy \[25 participants\] and combination therapy \[23 participants\]) and Phase 1b: 17 participants). No participants were enrolled in Cohort 2 and 6 of Phase 1b.
Participant milestones
| Measure |
Phase 1a: PF-07284890 50 mg QD
Participants received PF-07284890 50 milligrams (mg) oral dose once daily (QD) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD
Participants received PF-07284890 100 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 200 mg QD
Participants received PF-07284890 200 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 200 mg BID
Participants received PF-07284890 200 mg oral dose twice daily (BID) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a
STARTED
|
2
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4
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3
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3
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10
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3
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4
|
4
|
2
|
5
|
8
|
0
|
0
|
0
|
0
|
|
Phase 1a
COMPLETED
|
0
|
0
|
0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1a
NOT COMPLETED
|
2
|
4
|
3
|
3
|
10
|
3
|
4
|
4
|
2
|
5
|
8
|
0
|
0
|
0
|
0
|
|
Phase 1b
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
1
|
11
|
|
Phase 1b
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
4
|
1
|
11
|
Reasons for withdrawal
| Measure |
Phase 1a: PF-07284890 50 mg QD
Participants received PF-07284890 50 milligrams (mg) oral dose once daily (QD) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD
Participants received PF-07284890 100 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 200 mg QD
Participants received PF-07284890 200 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 200 mg BID
Participants received PF-07284890 200 mg oral dose twice daily (BID) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1a
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1a
Other (Death)
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1a
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1a
Progressive Disease
|
2
|
2
|
3
|
1
|
4
|
2
|
3
|
4
|
1
|
0
|
4
|
0
|
0
|
0
|
0
|
|
Phase 1a
Study terminated by sponsor
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Phase 1a
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Phase 1a
Global Deterioration Of Health Status
|
0
|
1
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1a
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Phase 1b
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Phase 1b
Other (Death)
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Phase 1b
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
5
|
|
Phase 1b
Study Terminated By Sponsor
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
|
Phase 1b
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
Baseline characteristics by cohort
| Measure |
Phase 1a: PF-07284890 50 mg QD
n=2 Participants
Participants received PF-07284890 50 milligrams (mg) oral dose once daily (QD) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 200 mg QD
n=3 Participants
Participants received PF-07284890 200 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 200 mg BID
n=3 Participants
Participants received PF-07284890 200 mg oral dose twice daily (BID) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 0.71 • n=5 Participants
|
56.3 Years
STANDARD_DEVIATION 12.61 • n=7 Participants
|
65.3 Years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
62.7 Years
STANDARD_DEVIATION 11.85 • n=4 Participants
|
55.9 Years
STANDARD_DEVIATION 15.95 • n=21 Participants
|
50.0 Years
STANDARD_DEVIATION 7.94 • n=8 Participants
|
59.8 Years
STANDARD_DEVIATION 3.20 • n=8 Participants
|
57.5 Years
STANDARD_DEVIATION 23.35 • n=24 Participants
|
40.5 Years
STANDARD_DEVIATION 27.58 • n=42 Participants
|
42.0 Years
STANDARD_DEVIATION 18.71 • n=42 Participants
|
45.0 Years
STANDARD_DEVIATION 13.89 • n=42 Participants
|
57.0 Years
STANDARD_DEVIATION NA • n=42 Participants
|
63.8 Years
STANDARD_DEVIATION 12.15 • n=36 Participants
|
31.0 Years
STANDARD_DEVIATION NA • n=36 Participants
|
50.8 Years
STANDARD_DEVIATION 12.96 • n=24 Participants
|
53.4 Years
STANDARD_DEVIATION 15.12 • n=135 Participants
|
|
Sex/Gender, Customized
Male
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
30 Participants
n=135 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
33 Participants
n=135 Participants
|
|
Sex/Gender, Customized
Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
9 Participants
n=24 Participants
|
56 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
|
Ethnicity, Customized
Hispanic/ Latino(a) or of Spanish Origin
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
|
Ethnicity, Customized
Not Hispanic/Latino(a)/of Spanish Origin
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
11 Participants
n=24 Participants
|
57 Participants
n=135 Participants
|
|
Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
|
Ethnicity, Customized
Not disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 Days)Population: The per protocol analysis set included all enrolled participants who had at least one dose of study treatment and either experienced DLT or did not have major treatment deviations during the DLT observation period.
DLT was defined as any adverse event (AE) or abnormal laboratory value which were related to study treatment and assessed as unrelated to disease (disease progression), occurring during the first 21 days of treatment that met at least 1 of the study specified criteria. DLTs were graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI-CTCAE), version (v) 5.0.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=2 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=1 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=7 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs): Phase 1a
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment or start of new anti-cancer therapy (-1 Day) whichever occurred first (maximum treatment exposure: 542 days; maximum follow-up: 572 days)Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in participant/ clinical study participant temporally associated with use of study intervention, whether/ not considered related to study intervention. TEAEs were defined as any AE that occurs during on-treatment period. The on-treatment period was defined as period that starts with first dose of study treatment and ends at last dose of study treatment +30 days, or start of new anti-cancer therapy \[- 1 day\], whichever occurred first. Serious TEAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity and might caused congenital anomaly/birth defect. Serious treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI-CTCAE v 5.0 (grade 3= severe, grade 4= life-threatening and grade 5= death related to AE). AEs included SAEs and all non-SAE.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1a
Participants with TEAEs
|
10 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1a
Participants with Serious TEAEs
|
4 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1a
Participants with serious treatment related TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1a
Participants with Grade 3 or 4 TEAEs
|
5 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1a
Participants with Grade 5 TEAEs
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment (maximum treatment exposure: 542 days; maximum follow-up: 572 days)Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The following hematology laboratory parameters were assessed: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, international normalized ratio (INR) increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. In this outcome measure, those number of participants are reported who had hematology laboratory abnormality in any parameter of any CTCAE Grades.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=2 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities of Any CTCAE Grade: Phase 1a
|
10 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment (maximum treatment exposure: 542 days; maximum follow-up: 572 days)Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
The following chemistry laboratory parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase (CPK) increased, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. In this outcome measure, those number of participants are reported who had chemistry laboratory abnormality in any parameter of any CTCAE Grades.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=2 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Chemistry Laboratory Abnormalities of Any CTCAE Grade: Phase 1a
|
10 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 542 days])Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
Dose interruption was defined as a planned dosing day with 0 mg total dose administered. Dose interruptions were applicable to unexpected dose interruptions. In this outcome measure, dose interruptions for any drug were considered.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Interruptions Due to TEAEs: Phase 1a
|
5 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 542 days])Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
A dose reduction was defined as the day when the actual dose was less than the planned dose at enrollment and the actual dose was greater than 0 mg (ie, missed doses were not counted as a reduction). In this outcome measure, dose reductions for any drug were considered.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Reduction Due to TEAEs: Phase 1a
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 542 days])Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
In this outcome measure, dose discontinuations for any drug due to TEAEs were considered.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Discontinuations Due to TEAEs: Phase 1a
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)Population: Extracranial response evaluable set included all participants enrolled and received at least one dose of study treatment and had measurable tumor at baseline and at least one post baseline extracranial assessment.
Extracranial response rate was defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) in extracranial lesions by Investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=1 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=8 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Extracranial Response Rate by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Phase 1b
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
12.5 Percentage of participants
Interval 0.3 to 52.7
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)Population: Intracranial response evaluable set included all participants enrolled and received at least one dose of study treatment and had measurable brain tumor at baseline and at least one post baseline intracranial assessment.
Intracranial response rate as assessed using modified RECIST (mRECIST) v 1.1., was defined as the percentage of participants with brain or central nervous system (CNS) involvement who achieved a CR or PR. CR: disappearance of all target and non-target lesions. For target lesions: Any pathological lymph nodes must be \<10 mm in the short axis. For non-target lesions: All lymph nodes identified as a site of disease at baseline must be non-pathological (eg, \<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intracranial Response Rate by mRECISTv1.1: Phase 1b
|
—
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 97.5
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)Population: The response evaluable population included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
ORR: percentage of participants with BOR of confirmed CR/PR by investigator assessment in intracranial metastasis (mRECISTv1.1) and extracranial lesions (RECISTv1.1). RECIST v1.1- CR: disappearance of all target and non-target lesions. Any pathological lymph node (non-target) must have reduction in short axis to \<10mm. PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. mRECIST- CR: disappearance of all target and non-target lesion. For target lesion: Any pathological lymph nodes must be \<10 mm in short axis. For non-target lesion: All lymph nodes identified as site of disease at baseline must be non-pathological (eg, \<10 mm short axis). PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=1 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR): Phase 1b
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
11.1 Percentage of participants
Interval 0.3 to 48.2
|
100 Percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)Population: The response evaluable population analyzed. The outcome measure was to be evaluated only in glioblastoma participants; apart from Cohort 5 all other cohorts did not have any glioblastoma participants. Hence, "Overall Number of Participants Analyzed" for these cohorts is "0" and for Cohort 5 it signifies participants evaluable for this outcome.
RANO response rate was defined as the percentage of glioblastoma participants who achieved a CR or PR per RANO. CR was defined as complete disappearance of all enhancing measurable and non-measurable disease sustained for more than or equal to (\>=) 4 weeks; no new lesions; stable or improved non-enhancing (T2/ \[fluid attenuated inversion recovery\] FLAIR) lesions; off steroids and neurological condition stable or improved. PR was defined as \>=50% decrease compared to baseline in the sum of the perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no progression of non-measurable disease; no new lesions; stable or improved non enhancing (T2/FLAIR) lesions on the same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at the time of the baseline scan and neurological condition stable or improved.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=2 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Response Rate Using Response Assessment in Neuro-Oncology (RANO) for Primary Brain Tumors: Phase 1b
|
—
|
—
|
—
|
50.0 Percentage of participants
Interval 1.3 to 98.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1 (C1D1); 24 hours was only for arms where study drug was administered as QD.Population: The pharmacokinetic (PK) parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment and have sufficient information to estimate at least 1 of the PK parameters of interest.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
PF-07284890
|
2466 Nanogram per milliliter (ng/mL)
Standard Deviation 1008.9
|
1692 Nanogram per milliliter (ng/mL)
Standard Deviation 541.62
|
1603 Nanogram per milliliter (ng/mL)
Standard Deviation 308.92
|
1983 Nanogram per milliliter (ng/mL)
Standard Deviation 789.96
|
NA Nanogram per milliliter (ng/mL)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 549 and 1040 ng/mL.
|
1771 Nanogram per milliliter (ng/mL)
Standard Deviation 1360.5
|
1893 Nanogram per milliliter (ng/mL)
Standard Deviation 968.86
|
2009 Nanogram per milliliter (ng/mL)
Standard Deviation 922.45
|
NA Nanogram per milliliter (ng/mL)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 2350 and 3220 ng/mL.
|
3286 Nanogram per milliliter (ng/mL)
Standard Deviation 1539.4
|
2339 Nanogram per milliliter (ng/mL)
Standard Deviation 1220.8
|
|
Maximum Observed Concentration (Cmax) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
432.3 Nanogram per milliliter (ng/mL)
Standard Deviation 153.53
|
457.5 Nanogram per milliliter (ng/mL)
Standard Deviation 174.37
|
NA Nanogram per milliliter (ng/mL)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 329 ng/mL.
|
396.2 Nanogram per milliliter (ng/mL)
Standard Deviation 208.55
|
287.0 Nanogram per milliliter (ng/mL)
Standard Deviation 127.42
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1; 24 hours was only for arms where study drug was administered as QD.Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
PF-07284890
|
3.95 Hours
Interval 1.0 to 6.0
|
4.94 Hours
Interval 2.07 to 5.93
|
5.93 Hours
Interval 2.32 to 6.18
|
5.87 Hours
Interval 4.08 to 5.97
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual values were 1.00 and 2.18 hours.
|
2.00 Hours
Interval 1.02 to 6.02
|
3.44 Hours
Interval 0.817 to 22.8
|
4.00 Hours
Interval 2.45 to 7.83
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual values were 1.85 and 5.85 hours.
|
3.92 Hours
Interval 2.0 to 7.7
|
3.12 Hours
Interval 0.967 to 7.73
|
|
Time for Cmax (Tmax) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
1.01 Hours
Interval 0.817 to 2.12
|
1.66 Hours
Interval 1.0 to 2.07
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual value was 2.03 hours.
|
1.00 Hours
Interval 1.0 to 2.08
|
1.00 Hours
Interval 0.967 to 2.07
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1; 24 hours was only for arms where study drug was administered as QD.Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
AUClast was determined using the linear/log trapezoidal method.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=10 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero to the Last Time Point of Quantifiable Concentration (AUClast) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
PF-07284890
|
13250 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 6943.8
|
14960 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 6415.5
|
16400 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 3404.4
|
8883 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 6085.0
|
NA Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 8330 and 9100 ng\*hr/mL.
|
8883 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 8251.1
|
21920 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 15893
|
9858 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 5391.9
|
NA Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 10800 and 17900 ng\*hr/mL.
|
17090 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 7615.8
|
11270 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 5458.1
|
|
Area Under the Plasma Concentration Time Curve From Time Zero to the Last Time Point of Quantifiable Concentration (AUClast) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
1710 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 1362.5
|
1639 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 673.91
|
NA Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 1490 ng\*hr/mL.
|
1289 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 358.45
|
979.4 Nanogram*hour per milliliter (ng*hr/mL)
Standard Deviation 227.90
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1; 24 hours was only for arms where study drug was administered as QD.Population: The PK parameter analysis population used. Here "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' =number of participants evaluable for specified rows. T1/2 could not be calculated for all participants due to challenges with determining T1/2 using an 8-hour profile particularly for C1D1 (where the pre-dose sample cannot be used), so the data could not be included and thus reported as 0 as applicable.
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=1 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Terminal Elimination Half Life (t½) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
PF-07284890
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 2.45 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 5.89 and 7.25 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 5.83 hours.
|
—
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 6.39 hours.
|
—
|
—
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 2.60 hours.
|
—
|
—
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 2.42 hours.
|
|
Terminal Elimination Half Life (t½) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 1.70 and 2.44 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 2.48 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 1.77 hours.
|
2.153 Hours
Standard Deviation 0.62389
|
2.443 Hours
Standard Deviation 0.91318
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1; 24 hours was only for arms where study drug was administered as QD.Population: PK parameter analysis population used. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' =number of participants evaluable for specified rows. AUCinf could not be calculated either due to either participants had insufficient sample(s) (e.g., sampling only through Tmax or 1 sample after) for analyses or t1/2 could not be determined, which affects the ability to calculate AUCinf and thus reported 0 as applicable.
AUCinf was calculated as AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. Those outcome measures are either due to either patient(s) has insufficient sample(s) (e.g., sampling only through Tmax or 1 sample after) for analyses or t1/2 could not be determined
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=2 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=1 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
PF-07284890
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 8030 and 12600 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 10200 and 14900 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 68500 ng\*hr/mL.
|
—
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 8990 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 17200 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 11200 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 9610 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 14000 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 29000 ng\*hr/mL.
|
15390 ng*hr/mL
Standard Deviation 9558.0
|
|
Area Under the Plasma Concentration Time Curve From Time Zero Extrapolated to Infinity (AUCinf) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
3128 ng*hr/mL
Standard Deviation 3244.1
|
1958 ng*hr/mL
Standard Deviation 871.79
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 1630 ng\*hr/mL.
|
1643 ng*hr/mL
Standard Deviation 631.36
|
1437 ng*hr/mL
Standard Deviation 628.11
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1; 24 hours was only for arms where study drug was administered as QD.Population: PK parameter analysis population used. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' =number of participants evaluable for specified rows. CL/F could not be calculated either due to either participants had insufficient sample(s) (e.g., sampling only through Tmax or 1 sample after) for analyses or t1/2 could not be determined, which affects the ability to calculate CL/F and thus reported 0 as applicable.
CL/F was calculated as Dose/AUCinf.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=1 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
PF-07284890
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 23.9 L/hr.
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 6.71 and 9.77 L/hr.
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 11.6 L/hr.
|
—
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 5.56 L/hr.
|
—
|
—
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 10.4 L/hr.
|
—
|
—
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 28.5 L/hr.
|
|
Apparent Oral Clearance (CL/F) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 25.5 and 57.5 L/hr.
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 26.1 L/hr.
|
NA Liter per hour (L/hr)
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 27.6 L/hr.
|
33.97 Liter per hour (L/hr)
Standard Deviation 13.627
|
40.48 Liter per hour (L/hr)
Standard Deviation 12.458
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1; 24 hours was only for arms where study drug was administered as QD.Population: PK parameter analysis population used. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' =number of participants evaluable for specified rows. Vz/F could not be calculated either due to either participants had insufficient sample(s) (e.g., sampling only through Tmax or 1 sample after) for analyses or t1/2 could not be determined, which affects the ability to calculate Vz/F and thus reported 0 as applicable.
Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=1 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
PF-07284890
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 84.3 L.
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 57.1 and 102 L.
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 97.8 L.
|
—
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 51.3 L.
|
—
|
—
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 39.0 L.
|
—
|
—
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 99.7 L.
|
|
Apparent Volume of Distribution (Vz/F) of PF-07284890 and Binimetinib for Single Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 89.7 and 141 L.
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 93.4 L.
|
NA Liter
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 70.5 L.
|
97.50 Liter
Standard Deviation 7.1757
|
139.3 Liter
Standard Deviation 52.043
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=7 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=2 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=1 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
PF-0728489
|
3489 ng/mL
Standard Deviation 1647.2
|
1102 ng/mL
Standard Deviation 178.49
|
1830 ng/mL
Standard Deviation 291.03
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 2610 and 4870 ng/mL.
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 943 and 1940 ng/mL.
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 1070 ng/mL.
|
1991 ng/mL
Standard Deviation 1325.5
|
2270 ng/mL
Standard Deviation 844.63
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 1970 and 3800 ng/mL.
|
3870 ng/mL
Standard Deviation 655.34
|
3613 ng/mL
Standard Deviation 739.91
|
|
Cmax of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
518.3 ng/mL
Standard Deviation 243.47
|
633.8 ng/mL
Standard Deviation 370.06
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 534 and 732 ng/mL.
|
674.0 ng/mL
Standard Deviation 276.30
|
457.3 ng/mL
Standard Deviation 180.50
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=7 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=2 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=1 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
PF-07284890
|
3.90 Hours
Interval 1.05 to 5.75
|
4.03 Hours
Interval 2.0 to 4.13
|
2.15 Hours
Interval 2.08 to 4.03
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual values were 2.20 and 4.13 hours.
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual values were 1.00 and 2.02 hours.
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual values was 1.07 hours.
|
3.95 Hours
Interval 2.05 to 7.8
|
2.08 Hours
Interval 2.03 to 4.0
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual values were 2.22 and 3.92 hours.
|
2.01 Hours
Interval 2.0 to 4.0
|
2.03 Hours
Interval 0.983 to 3.92
|
|
Tmax of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
1.93 Hours
Interval 1.0 to 7.8
|
0.977 Hours
Interval 0.0 to 2.4
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual values were 0.950 and 1.85 hours.
|
1.01 Hours
Interval 1.0 to 1.92
|
1.04 Hours
Interval 0.967 to 2.25
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=7 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=2 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=1 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUCtau) of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
PF-07284890
|
30030 ng*hr/mL
Standard Deviation 16644
|
10260 ng*hr/mL
Standard Deviation 813.65
|
16530 ng*hr/mL
Standard Deviation 1616.6
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 15200 and 47600 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 10600 and 12300 ng\*hr/mL.
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 6630 ng\*hr/mL.
|
15370 ng*hr/mL
Standard Deviation 5218.1
|
17450 ng*hr/mL
Standard Deviation 7857.3
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 14300 and 32800 ng\*hr/mL.
|
28550 ng*hr/mL
Standard Deviation 5569.3
|
29400 ng*hr/mL
Standard Deviation 9041.5
|
|
Area Under the Plasma Concentration Time Curve Over the Dosing Interval (AUCtau) of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
2740 ng*hr/mL
Standard Deviation 1196.2
|
3150 ng*hr/mL
Standard Deviation 1749.5
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 1880 and 4610 ng\*hr/mL.
|
2458 ng*hr/mL
Standard Deviation 341.89
|
2420 ng*hr/mL
Standard Deviation 1306.5
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=7 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=2 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=1 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
PF-07284890
|
1773 ng/mL
Standard Deviation 1344.9
|
130.2 ng/mL
Standard Deviation 67.258
|
198.0 ng/mL
Standard Deviation 155.75
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 267 and 3270 ng/mL.
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 137 and 195 ng/mL.
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 351 ng/mL.
|
181.7 ng/mL
Standard Deviation 99.887
|
822.3 ng/mL
Standard Deviation 441.12
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 435 and 1290 ng/mL.
|
1223 ng/mL
Standard Deviation 602.84
|
1625 ng/mL
Standard Deviation 612.23
|
|
Lowest Concentration Observed During the Dosing Interval (Cmin) of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
73.57 ng/mL
Standard Deviation 28.576
|
127.1 ng/mL
Standard Deviation 66.662
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 82.3 and 269 ng/mL.
|
67.13 ng/mL
Standard Deviation 26.085
|
94.72 ng/mL
Standard Deviation 32.053
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
CL/F was calculated as Dose/AUCinf.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=7 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=2 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=1 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
PF-07284890
|
13.14 L/hr
Standard Deviation 7.2301
|
9.793 L/hr
Standard Deviation 0.82403
|
12.20 L/hr
Standard Deviation 1.2767
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 4.20 and 13.2 L/hr.
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 4.07 and 4.72 L/hr.
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 67.9 L/hr.
|
7.147 L/hr
Standard Deviation 2.8564
|
6.480 L/hr
Standard Deviation 2.3107
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 4.57 and 10.5 L/hr.
|
8.138 L/hr
Standard Deviation 1.7244
|
11.18 L/hr
Standard Deviation 4.1290
|
|
CL/F of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
18.27 L/hr
Standard Deviation 6.4034
|
22.42 L/hr
Standard Deviation 20.947
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 9.75 and 23.9 L/hr.
|
18.60 L/hr
Standard Deviation 2.5073
|
22.54 L/hr
Standard Deviation 10.178
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: PK parameter analysis population used. "Overall Number of Participants Analyzed"= participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' =number of participants evaluable for specified rows. Vz/F could not be calculated either due to either participants had insufficient sample(s) (e.g., sampling only through Tmax or 1 sample after) for analyses or t1/2 could not be determined, which affects the ability to calculate Vz/F and thus reported 0 as applicable.
Vz/F was calculated as Dose/(AUCinf \* kel) where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=1 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=1 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vz/F of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
PF-07284890
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 86.4 L.
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 59.5 and 141 L.
|
126.4 Litre
Standard Deviation 64.519
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 44.2 L.
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 50.6 L.
|
—
|
—
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 49.8 L.
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value were 28.1 and 53.9 L.
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value were 35.7 and 50.1 L.
|
—
|
|
Vz/F of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 85.9 L.
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 57.0 L.
|
NA Litre
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 52.5 L.
|
SECONDARY outcome
Timeframe: Pre-dose (24 hours post-dose concentration), 1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. In the determination of the t1/2, steady-state was assumed and the pre-dose value was used for the 24-hour post-dose value, which could have enabled the reporting of the t1/2 value higher than 8 hours.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=1 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=1 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
t½ of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
PF-07284890
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 4.17 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values were 4.54 and 9.15 hours.
|
7.430 Hours
Standard Deviation 4.1000
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 2.32 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 8.63 hours.
|
—
|
—
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 3.80 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value were 3.56 and 4.27 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value were 3.37 and 4.23 hours.
|
—
|
|
t½ of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 2.49 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 1.88 hours.
|
NA Hours
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 3.98 hours.
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D1 and C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Rac was defined as area under the plasma concentration-time curve over the dosing interval at steady state (AUCss,τ) divided by area under the plasma concentration-time curve over the dosing interval from a single dose (AUCsd,τ).
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=1 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Accumulation Ratio (Rac) of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
PF-07284890
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratio) was 2.22.
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratios) were 0.435 and 1.02.
|
1.024 Ratio
Standard Deviation 0.11484
|
—
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratios) were 1.16 and 1.48.
|
—
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratios) were 0.583 and 2.21.
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratio) was 1.65.
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratio) was 1.13.
|
—
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratios) were 1.49 and 1.59.
|
|
Accumulation Ratio (Rac) of PF-07284890 and Binimetinib for Multiple Dose: Phase 1a
Binimetinib
|
—
|
—
|
—
|
—
|
—
|
—
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratio) was 2.57.
|
1.609 Ratio
Standard Deviation 0.54869
|
NA Ratio
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual (ratio) was 2.87.
|
1.950 Ratio
Standard Deviation 0.53560
|
2.088 Ratio
Standard Deviation 1.0472
|
SECONDARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 542 days)Population: Extracranial response evaluable set included all participants enrolled and received at least one dose of study treatment and had measurable tumor at baseline and at least one post baseline extracranial assessment.
Extracranial response rate was defined as the percentage of participants with a BOR of CR or confirmed PR in extracranial lesions by Investigator assessment per RECIST v1.1. CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=2 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Extracranial Response Rate by RECISTv1.1: Phase 1a
|
0 Percentage of participants
Interval 0.0 to 45.9
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 542 days)Population: Intracranial response evaluable set included all participants enrolled and received at least one dose of study treatment and had measurable brain tumor at baseline and at least one post baseline intracranial assessment. Here "Overall Number of Participants Analyzed" as "0" signifies there was no participant evaluable in specified analysis set.
Intracranial response rate as assessed using modified mRECIST v 1.1., was defined as the percentage of participants with brain or CNS involvement who achieved a CR or PR. CR: disappearance of all target and non-target lesions. For target lesions: Any pathological lymph nodes must be \<10 mm in the short axis. For non-target lesions: All lymph nodes identified as a site of disease at baseline must be non-pathological (eg, \<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=2 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=1 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=1 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=1 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intracranial Response Rate by mRECISTv1.1: Phase 1a
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
—
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
SECONDARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 542 days)Population: The response evaluable population included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
ORR: percentage of participants with BOR of confirmed CR/PR by investigator assessment in intracranial metastasis (mRECISTv1.1) and extracranial lesions (RECISTv1.1). RECIST v1.1- CR: disappearance of all target and non-target lesions. Any pathological lymph node (non-target) must have reduction in short axis to \<10mm. PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. mRECIST- CR: disappearance of all target and non-target lesion. For target lesion: Any pathological lymph nodes must be \<10 mm in short axis. For non-target lesion: All lymph nodes identified as site of disease at baseline must be non-pathological (eg, \<10 mm short axis). PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=6 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=3 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=2 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 Participants
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 Participants
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=3 Participants
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=5 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
ORR by RECISTv1.1: Phase 1a
|
0 Percentage of participants
Interval 0.0 to 45.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 84.2
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 70.8
|
0 Percentage of participants
Interval 0.0 to 52.2
|
SECONDARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 542 days)Population: The response evaluable population included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment. The outcome measure was to be evaluated only in glioblastoma participants. "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome and "0" represents no glioblastoma participants for respective reporting arms.
RANO response rate was defined as the percentage of glioblastoma participants who achieved a CR or PR per RANO. CR was defined as complete disappearance of all enhancing measurable and non-measurable disease sustained for \>= 4 weeks; no new lesions; stable or improved non-enhancing (T2/FLAIR) lesions; off steroids and neurological condition stable or improved. PR was defined as \>=50% decrease compared to baseline in the sum of the perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no progression of non-measurable disease; stable or improved non enhancing (T2/FLAIR) lesions on the same or lower dose of corticosteroids compared with baseline scan; the corticosteroid dose at the time of the scan evaluation should be no greater than the dose at the time of the baseline scan and neurological condition stable or improved.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
n=3 Participants
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=1 Participants
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=2 Participants
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate as Per RANO for Brain Tumours: Phase 1a
|
0 Percentage of participants
Interval 0.0 to 70.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
—
|
0 Percentage of participants
Interval 0.0 to 84.2
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (maximum treatment exposure: 400 days, maximum follow up: 430 days)Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
An AE was any untoward medical occurrence in participant/ clinical study participant temporally associated with use of study intervention, whether/ not considered related to study intervention. TEAEs were defined as any AE that occurs during on-treatment period. The on-treatment period was defined as period that starts with first dose of study treatment and ends at last dose of study treatment +30 days, or start of new anti-cancer therapy \[- 1 day\], whichever occurred first. Serious TEAEs were any untoward medical occurrence at any dose that: suspected to cause death; life-threatening; required hospitalization; persistent/significant disability/incapacity and might caused congenital anomaly/birth defect. Serious treatment related TEAEs were related to study treatment and relatedness was judged by investigator. TEAEs were graded according to NCI-CTCAE v 5.0 (grade 3= severe, grade 4= life-threatening and grade 5= death related to AE). AEs included SAEs and all non-SAE.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs, Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1b
Participants with TEAEs
|
—
|
4 Participants
|
1 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1b
Participants with Serious TEAEs
|
—
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1b
Participants with Serious Treatment-Related TEAEs
|
—
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1b
Participants with Grade 3 or 4 TEAEs
|
—
|
3 Participants
|
0 Participants
|
6 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With TEAEs, Serious TEAEs, Serious Treatment Related TEAEs, Grade 3 or 4 TEAEs and Grade 5 TEAEs by NCI CTCAE v5.0: Phase 1b
Participants with Grade 5 TEAEs
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment (maximum treatment exposure: 400 days, maximum follow up: 430 days)Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
The following hematology laboratory parameters were assessed: activated partial thromboplastin time prolonged, anemia, hemoglobin increased, INR increased, leukocytosis, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased, platelet count decreased and white blood cell decreased. Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. In this outcome measure, those number of participants are reported who had hematology laboratory abnormality in any parameter of any CTCAE Grades.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Laboratory Abnormalities: Phase 1b
|
—
|
4 Participants
|
1 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment (maximum treatment exposure: 400 days, maximum follow up: 430 days)Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
The following chemistry laboratory parameters were assessed: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, CPK increased, creatinine increased, hypercalcemia, hyperkalemia, hypermagnesemia, hypernatremia, hypoalbuminemia, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia and hyponatremia. Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. In this outcome measure, those number of participants are reported who had chemistry laboratory abnormality in any parameter of any CTCAE Grades.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Chemistry Laboratory Abnormalities: Phase 1b
|
—
|
4 Participants
|
1 Participants
|
11 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 400 days])Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
Dose interruption was defined as a planned dosing day with 0 mg total dose administered. Dose interruptions were applicable to unexpected dose interruptions. In this outcome measure, dose interruptions for any drug were considered.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Interruptions Due to TEAEs: Phase 1b
|
—
|
4 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 400 days])Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
A dose reduction was defined as the day when the actual dose was less than the planned dose at enrollment and the actual dose was greater than 0 mg (ie, missed doses were not counted as a reduction). In this outcome measure, dose reductions for any drug were considered.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Reduction Due to TEAEs: Phase 1b
|
—
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During study treatment (from first dose of study treatment [Day 1] up to last dose of study treatment [maximum treatment exposure: 400 days])Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
In this outcome measure, dose discontinuations for any drug due to TEAEs were considered.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Discontinuations Due to TEAEs: Phase 1b
|
—
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1Population: TThe PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-07284890 and Binimetinib for Single Dose: Phase 1b
PF-07284890
|
—
|
3730 ng/mL
Standard Deviation 639.06
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 7380 ng/mL.
|
3406 ng/mL
Standard Deviation 1558.8
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 4730 ng/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-07284890 and Binimetinib for Single Dose: Phase 1b
Binimetinib
|
—
|
400.0 ng/mL
Standard Deviation 120.65
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 748 ng/mL.
|
387.2 ng/mL
Standard Deviation 168.62
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 416 ng/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-07284890 and Binimetinib for Single Dose: Phase 1b
PF-07284890
|
—
|
2.25 Hours
Interval 2.08 to 4.0
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual value was 4.07 hours.
|
3.88 Hours
Interval 2.0 to 4.08
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual value was 2.17 hours.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of PF-07284890 and Binimetinib for Single Dose: Phase 1b
Binimetinib
|
—
|
1.25 Hours
Interval 1.0 to 2.07
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual value was 2.18 hours.
|
1.95 Hours
Interval 0.917 to 3.82
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence median and full range not reported. Individual value was 1.00 hours.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6, 8 and 24 hours post-dose on C1D1Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
AUClast was determined using the linear/log trapezoidal method.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=3 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUClast of PF-07284890 and Binimetinib for Single Dose: Phase 1b
PF-07284890
|
—
|
9593 ng*hr/mL
Standard Deviation 1633.7
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 9890 ng\*hr/mL.
|
8033 ng*hr/mL
Standard Deviation 3703.1
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 19000 ng\*hr/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUClast of PF-07284890 and Binimetinib for Single Dose: Phase 1b
Binimetinib
|
—
|
932.7 ng*hr/mL
Standard Deviation 208.62
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 511 ng\*hr/mL.
|
967.7 ng*hr/mL
Standard Deviation 423.36
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual value was 1360 ng\*hr/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
PF-07284890
|
—
|
2897 ng/mL
Standard Deviation 925.00
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 7380 ng/mL.
|
4301 ng/mL
Standard Deviation 1647.6
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 4730 ng/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
Binimetinib
|
—
|
557.5 ng/mL
Standard Deviation 223.36
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 748 ng/mL.
|
671.4 ng/mL
Standard Deviation 380.67
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 416 ng/mL
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
PF-07284890
|
—
|
3.50 Hours
Interval 1.75 to 3.92
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 4.02 hours.
|
2.08 Hours
Interval 1.88 to 4.0
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 3.87 hours.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
Binimetinib
|
—
|
1.92 Hours
Interval 1.0 to 3.97
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 1.00 hours.
|
1.50 Hours
Interval 0.9 to 4.0
|
NA Hours
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 0.983 hours.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUCtau of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
PF-07284890
|
—
|
20130 ng*hr/mL
Standard Deviation 7072.0
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 65900 ng\*hr/mL.
|
31740 ng*hr/mL
Standard Deviation 13933
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 36300 ng\*hr/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUCtau of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
Binimetinib
|
—
|
2680 ng*hr/mL
Standard Deviation 408.00
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 3730 ng\*hr/mL.
|
3011 ng*hr/mL
Standard Deviation 1469.6
|
NA ng*hr/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 2270 ng\*hr/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmin of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
PF-07284890
|
—
|
755.7 ng/mL
Standard Deviation 446.61
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 3490 ng/mL.
|
1512 ng/mL
Standard Deviation 947.80
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 1310 ng/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmin of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
Binimetinib
|
—
|
73.98 ng/mL
Standard Deviation 31.319
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 146 ng/mL.
|
120.4 ng/mL
Standard Deviation 74.848
|
NA ng/mL
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 80.0 ng/mL.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose,1, 2, 4, 6 and 8 hours post dose on C1D15Population: The PK parameter analysis population included all enrolled participants treated who did not have protocol deviations influencing PK parameter assessment, and have sufficient information to estimate at least 1 of the PK parameters of interest. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure and contributed to data; 'Number Analyzed' signifies number of participants evaluable for the specified rows.
CL/F was calculated as Dose/AUCinf.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
CL/F of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
PF-07284890
|
—
|
16.03 L/hr
Standard Deviation 4.7983
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 4.55 L/hr.
|
11.02 L/hr
Standard Deviation 4.3338
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 8.26 L/hr.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CL/F of PF-07284890 and Binimetinib for Multiple Dose: Phase 1b
Binimetinib
|
—
|
17.13 L/hr
Standard Deviation 2.9273
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 12.0 L/hr.
|
21.19 L/hr
Standard Deviation 16.343
|
NA L/hr
Standard Deviation NA
As pre-specified in statistical analysis, statistics was to be provided only with \>=3 evaluable measurements, hence mean and SD not reported. Individual values was 19.9 L/hr.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose until CR or PR or SD (maximum treatment exposure: 400 days)Population: Intracranial response evaluable set included all participants enrolled and received at least one dose of study treatment and had measurable brain tumor at baseline and at least one post baseline intracranial assessment.
DCR: percentage of participants with BOR of CR, PR/ SD, Non-CR/Non-PD by Investigator assessment. CR: disappearance of all target and non-target lesions. For target lesions: Any pathological lymph nodes must be \<10 mm in short axis. For non-target lesions: All lymph nodes identified as site of disease at baseline must be non-pathological. PR: At least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive disease (PD). PD: for target lesions- At least 20% increase in sum of diameters of target lesions, taking as reference smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase of at least 5 mm. PD for non-target lesions- unequivocal progression of existing non-target lesions. Non-CR/Non-PD: persistence of 1/ more non-target lesion(s) identified as site of disease.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intracranial Disease Control Rate (DCR) Per mRECIST v1.1: Phase1b
|
—
|
50.0 Percentage of participants
Interval 1.3 to 98.7
|
0 Percentage of participants
Interval 0.0 to 97.5
|
100.0 Percentage of participants
Interval 29.2 to 100.0
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose until CR or PR or SD (maximum treatment exposure: 400 days)Population: The response evaluable population included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment.
DCR: percentage of participants with BOR of CR, PR or SD, Non-CR/Non-PD by Investigator assessment. CR: disappearance of all target \& non-target lesions. For target lesions: Any pathological lymph nodes must be \<10 mm in short axis. For non-target lesions: All lymph nodes identified as site of disease at baseline must be non-pathological. PR: At least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. PD: for target lesions- At least 20% increase in sum of diameters of target lesions, taking as reference smallest sum of diameters recorded since treatment started. In addition, sum must have an absolute increase of at least 5 mm. PD for non-target lesions- unequivocal progression of existing non-target lesions. Non-CR/Non-PD: persistence of 1/ more non-target lesion(s) identified as site of disease.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=1 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Disease Control Rate (DCR) Per RECIST v1.1: Phase1b
|
—
|
0 Percentage of participants
Interval 0.0 to 97.5
|
0 Percentage of participants
Interval 0.0 to 97.5
|
66.7 Percentage of participants
Interval 29.9 to 92.5
|
100.0 Percentage of participants
Interval 2.5 to 100.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose of study treatment until first documentation of PD or death due to any cause or censoring date whichever occurred first (maximum treatment exposure: 400 days)Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
PFS was defined as the time from date of the first dose of study treatment to the earliest documented disease progression by Investigator assessment, or death due to any cause, whichever occurred first. PD: for target lesions- At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded since the treatment started . In addition, the sum must have an absolute increase of at least 5 mm. PD for non-target lesions- unequivocal progression of existing non-target lesions. If a participant had not had a PFS event at the time of the analysis cutoff or at the start of any new anticancer therapy, PFS was censored at the date of last adequate tumor assessment. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intracranial Progression Free Survival (PFS) by mRECISTv1.1: Phase1b
|
—
|
NA Months
Interval 1.7 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated as there was only 1 participant evaluable with PFS of 1.4 months.
|
NA Months
Interval 4.1 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% Confidence Interval (CI) could not be calculated as participant did not have event.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until first documentation of PD or death due to any cause or censoring date (maximum treatment exposure: 400 days)Population: The safety analysis set included all enrolled participants who received at least one dose of study intervention.
PFS was defined as the time from date of the first dose of study treatment to the earliest documented disease progression by Investigator assessment, or death due to any cause, whichever occurred first. PD: for target lesions- at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is smallest on study). In addition to the relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered a sign of progression. PD for non-target lesions- unequivocal progression of existing non-target lesion. If a participant had not had a PFS event at the time of the analysis cutoff or at the start of any new anticancer therapy, PFS was censored at the date of last adequate tumor assessment. Overall PFS included evaluation for brain metastasis and extracranial lesions. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Progression Free Survival (PFS): Phase1b
|
—
|
1.7 Months
Interval 1.1 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated as there was only 1 participant evaluable with PFS of 1.4 months.
|
4.1 Months
Interval 1.1 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated as participant did not have event.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment until death due to any cause or censoring date (maximum treatment exposure: 400 days)Population: The full analysis set includes all enrolled participants.
Overall survival was defined as the time from the date of first study treatment to the date of death due to any cause. Participants who were still alive at the end of the study or lost to follow-up were censored at the last date they were known to be alive. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS): Phase1b
|
—
|
5.3 Months
Interval 1.1 to
Median and upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated as participant did not had event.
|
12.1 Months
Interval 3.7 to
Upper limit of 95% CI could not be calculated due to insufficient number of participants with events.
|
NA Months
Median and 95% CI could not be calculated as participant did not had event.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From CR or PR until first documented PD or death due to any cause (maximum treatment exposure: 400 days)Population: Intracranial response evaluable set included all participants enrolled and received at least one dose of study treatment and had measurable brain tumor at baseline and at least one post baseline intracranial assessment. Here "Overall Number of Participants Analyzed" as "0" signified participants did not have CR or PR.
DOR was defined as the time from date of the first radiographic response (CR or PR) to the earliest documented PD or death due to any cause. CR: disappearance of all target and non-target lesions. For target lesions: Any pathological lymph nodes must be \<10 mm in the short axis. For non-target lesions: All lymph nodes identified as a site of disease at baseline must be non-pathological (eg, \<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: for target lesions- At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase of at least 5 mm. PD for non-target lesions- unequivocal progression of existing non target lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From CR or PR until first documented PD or death due to any cause (maximum treatment exposure: 400 days)Population: The response evaluable population included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment. Here "Overall Number of Participants Analyzed" signifies participants who have CR or PR and "0" signified participants did not have CR or PR for respective arms.
DOR: time from date of first radiographic response (CR/PR) to earliest documented PD/ death due to any cause.CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: for target lesions- At least 20% increase in sum of diameters of target lesions, taking as reference smallest sum of diameters recorded since treatment started. PD for non-target lesions- unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=1 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall DOR by RECIST v1.1: Phase1b
|
—
|
—
|
—
|
NA Months
Since only 1 participant was evaluable hence median and 95%CI could not be calculated. Individual DOR was 8.38 months.
|
NA Months
Since only 1 participant was evaluable hence median and 95% CI could not be calculated. Individual DOR was 11.3 months.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)Population: Intracranial response evaluable set included all participants enrolled and received at least one dose of study treatment and had measurable brain tumor at baseline and at least one post baseline intracranial assessment.
Time to response is the time from treatment start to date of first documentation of objective response (PR or CR). CR: disappearance of all target and non-target lesions. For target lesions: Any pathological lymph nodes must be \<10 mm in the short axis. For non-target lesions: All lymph nodes identified as a site of disease at baseline must be non-pathological (eg, \<10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=2 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=3 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Intracranial Time to Response (TTR) by mRECIST v1.1: Phase1b
|
—
|
NA Months
Median and 95%CI could not be estimated as participant (s) did not have event.
|
NA Months
Median and 95%CI could not be estimated as participant (s) did not have event.
|
NA Months
Median and 95%CI could not be estimated as participant (s) did not have event.
|
NA Months
Median and 95%CI could not be estimated as participant (s) did not have event.
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose until CR or PR (maximum treatment exposure: 400 days)Population: The response evaluable population included all participants who received at least one dose of study treatment and had measurable disease at baseline and at least one post baseline disease assessment. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Time to response is the time from treatment start to date of first documentation of objective response (PR or CR). CR: disappearance of all target and non-target lesions. Any pathological lymph nodes (non-target) must have reduction in short axis to \< 10 mm. PR: at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response evaluable population.
Outcome measures
| Measure |
Phase 1a: PF-07284890 300 mg BID
Participants received PF-07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=1 Participants
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 Participants
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=9 Participants
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 Participants
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF-07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
Participants received PF-07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Participants received PF-07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall TTR by RECIST v1.1: Phase1b
|
—
|
NA Months
Median and 95%CI could not be estimated as participant did not have an event.
|
NA Months
Median and 95%CI could not be estimated as participant did not have an event.
|
NA Months
Median and 95%CI could not be estimated as there were insufficient number of participants with events.
|
NA Months
Since only 1 participant was evaluable hence median and 95%CI could not be calculated. Individual TTR was 1.4 months.
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1a: PF-07284890 50 mg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 1a: PF-07284890 100 mg QD
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 1a: PF-07284890 200 mg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1a: PF-07284890 200 mg BID
Serious events: 3 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1a: PF-07284890 300 mg BID
Serious events: 4 serious events
Other events: 10 other events
Deaths: 4 deaths
Phase 1a: PF-07284890 450 mg BID
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
Serious events: 2 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
Serious events: 3 serious events
Other events: 8 other events
Deaths: 4 deaths
Phase 1b: Cohort 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b: Cohort 3
Serious events: 3 serious events
Other events: 4 other events
Deaths: 3 deaths
Phase 1b: Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1b: Cohort 5
Serious events: 3 serious events
Other events: 11 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Phase 1a: PF-07284890 50 mg QD
n=2 participants at risk
Participants received PF- 07284890 50 milligrams (mg) oral dose once daily (QD) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD
n=4 participants at risk
Participants received PF- 07284890 100 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 200 mg QD
n=3 participants at risk
Participants received PF- 07284890 200 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first
|
Phase 1a: PF-07284890 200 mg BID
n=3 participants at risk
Participants received PF- 07284890 200 mg oral dose twice daily (BID) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID
n=10 participants at risk
Participants received PF- 07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 participants at risk
Participants received PF- 07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 participants at risk
Participants received PF- 07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 participants at risk
Participants received PF- 07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 participants at risk
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 participants at risk
Participants received PF- 07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 participants at risk
Participants received PF- 07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 participants at risk
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF- 07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 participants at risk
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF- 07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 participants at risk
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF- 07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 participants at risk
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF- 07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Disease progression
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
66.7%
2/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
40.0%
2/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
66.7%
2/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Vasogenic cerebral oedema
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
Other adverse events
| Measure |
Phase 1a: PF-07284890 50 mg QD
n=2 participants at risk
Participants received PF- 07284890 50 milligrams (mg) oral dose once daily (QD) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD
n=4 participants at risk
Participants received PF- 07284890 100 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 200 mg QD
n=3 participants at risk
Participants received PF- 07284890 200 mg oral dose QD in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first
|
Phase 1a: PF-07284890 200 mg BID
n=3 participants at risk
Participants received PF- 07284890 200 mg oral dose twice daily (BID) in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID
n=10 participants at risk
Participants received PF- 07284890 300 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 450 mg BID
n=3 participants at risk
Participants received PF- 07284890 450 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg QD + Binimetinib 45 mg BID
n=4 participants at risk
Participants received PF- 07284890 100 mg oral dose QD in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 100 mg BID + Binimetinib 45 mg BID
n=4 participants at risk
Participants received PF- 07284890 100 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 150 mg BID + Binimetinib 45 mg BID
n=2 participants at risk
Participants received PF- 07284890 150 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 225 mg BID + Binimetinib 45 mg BID
n=5 participants at risk
Participants received PF- 07284890 225 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1a: PF-07284890 300 mg BID + Binimetinib 45 mg BID
n=8 participants at risk
Participants received PF- 07284890 300 mg oral dose BID in combination with binimetinib 45 mg oral dose BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 1
n=1 participants at risk
Cohort 1 included melanoma participants with asymptomatic brain metastases and no prior B-type Raf proto-oncogene (BRAF) inhibitor therapy. Participants received PF- 07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 3
n=4 participants at risk
Cohort 3 included melanoma participants with asymptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF- 07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 4
n=1 participants at risk
Cohort 4 included melanoma participants with symptomatic brain metastases and with prior BRAF inhibitor therapy. Participants received PF- 07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
Phase 1b: Cohort 5
n=11 participants at risk
Cohort 5 included participants with a mixture of tumor types, any brain disease and with or without prior BRAF inhibitor therapy. Participants received PF- 07284890 300 mg oral dose QD in combination with binimetinib 45 mg BID in a 21-day cycle. Participants continued treatment until disease progression, participant refusal, unacceptable toxicity, or up to 2 years, whichever occurred first.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Balance disorder
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
40.0%
4/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
40.0%
2/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
27.3%
3/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Congenital, familial and genetic disorders
Brugada syndrome
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Asthenopia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Cataract
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Central serous chorioretinopathy
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Dyschromatopsia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Eye disorder
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Myopia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Photopsia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Serous retinopathy
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Subretinal fluid
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Visual impairment
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
27.3%
3/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
30.0%
3/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
2/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
60.0%
3/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
37.5%
3/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
45.5%
5/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Glossodynia
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
75.0%
3/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
40.0%
2/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
4/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
54.5%
6/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
75.0%
3/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
37.5%
3/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
27.3%
3/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Chest pain
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Chills
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Fatigue
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
66.7%
2/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
4/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
60.0%
3/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
45.5%
5/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Feeling cold
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Generalised oedema
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Localised oedema
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Malaise
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Oedema
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Oedema peripheral
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
30.0%
3/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
27.3%
3/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Pain
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
30.0%
3/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
37.5%
3/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Suprapubic pain
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
General disorders
Temperature intolerance
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Candida infection
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Furuncle
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Impetigo
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Skin bacterial infection
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
37.5%
3/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
40.0%
2/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Blood creatine increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
54.5%
6/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
International normalised ratio increased
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
27.3%
3/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
27.3%
3/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Troponin I increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Troponin increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Visual acuity tests
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
Weight increased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
37.5%
3/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Seizure
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
4/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Nervous system disorders
Taste disorder
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Anxiety
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
30.0%
3/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Keratosis pilaris
|
50.0%
1/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
1/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
20.0%
2/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
40.0%
4/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
18.2%
2/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
50.0%
2/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
12.5%
1/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
10.0%
1/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
33.3%
1/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
1/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
25.0%
2/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
100.0%
1/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/10 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/3 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/2 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/5 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/8 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/4 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
0.00%
0/1 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
9.1%
1/11 • From first dose of study treatment (Day 1) up to 30 days post last dose of study treatment/start of new anti-cancer therapy (-1 Day) whichever occurred first (For Phase 1a: maximum treatment exposure: 542 days; maximum follow-up: 572 days) and Phase 1b: (maximum treatment exposure: 400 days, maximum follow up: 430 days)
Same event may appear as both non-SAE and SAE but are distinct events. An event may be categorised as serious in 1 subject and non-serious in another, or a subject may have experienced both SAE and non-SAE. The safety analysis set included all enrolled participants who received at least one dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER