Trial Outcomes & Findings for Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors (NCT NCT03379259)
NCT ID: NCT03379259
Last Updated: 2024-10-26
Results Overview
Adverse events were assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE Version 4.03 Serious Adverse Events (SAEs) were monitored from the date of informed consent. All adverse events (AEs) and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
39 participants
Primary outcome timeframe
Up to 33.5 months
Results posted on
2024-10-26
Participant Flow
This study was conducted at 8 study centers in Australia, 1 study center in New Zealand, and 3 study centers in Spain. A total of 39 patients were enrolled in the study and all received ≥ 1 dose of study drug.
Participant milestones
| Measure |
Phase 1A: BGB-A333 450 mg
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900mg
BGB-A333 900mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1800 mg
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
3
|
12
|
12
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
0
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
3
|
9
|
7
|
Reasons for withdrawal
| Measure |
Phase 1A: BGB-A333 450 mg
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900mg
BGB-A333 900mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1800 mg
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Overall Study
Commenced new anti-cancer therapy
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
1
|
2
|
1
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
2
|
0
|
|
Overall Study
Study terminated by sponsor
|
0
|
0
|
0
|
1
|
1
|
4
|
|
Overall Study
Disease progression
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Deteriorating condition
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900mg
n=3 Participants
BGB-A333 900mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.0 years
STANDARD_DEVIATION 7.21 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 11.24 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 14.52 • n=5 Participants
|
58.0 years
STANDARD_DEVIATION 16.52 • n=4 Participants
|
65.3 years
STANDARD_DEVIATION 10.85 • n=21 Participants
|
67.5 years
STANDARD_DEVIATION 8.52 • n=8 Participants
|
63.31 years
STANDARD_DEVIATION 11.12 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
21 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
|
Race (NIH/OMB)
Unknown or 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
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Programmed death-ligand 1 (PD-L1) Status
Positive
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
4 participants
n=21 Participants
|
6 participants
n=8 Participants
|
15 participants
n=8 Participants
|
|
Programmed death-ligand 1 (PD-L1) Status
Negative
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
7 participants
n=21 Participants
|
6 participants
n=8 Participants
|
21 participants
n=8 Participants
|
|
Programmed death-ligand 1 (PD-L1) Status
Missing
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=8 Participants
|
3 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Adverse events were assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE Version 4.03 Serious Adverse Events (SAEs) were monitored from the date of informed consent. All adverse events (AEs) and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events
Any Treatment Emergent Adverse Event (TEAE)
|
3 Participants
|
12 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
12 Participants
|
|
Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events
Serious TEAE
|
1 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Complete physical examination including an evaluation of 1) head, eyes, ears, nose, throat, 2) cardiovascular, 3) dermatological, 4) musculoskeletal, 5) respiratory, 6) gastrointestinal, and 7) neurological systems was required to be performed at Screening. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations were performed. Clinically significant Ophthalmology abnormalities were collected from case report forms. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Central ECG data was used and the abnormality was determined by the evaluator (Investigating physician). Multiple tests such as QT, HR, PR, RR were used by the evaluator to determine abnormality. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG)
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
5 participants
|
9 participants
|
PRIMARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Lab abnormality was based on ANRIND: if the measurement value \> upper limit of normal (ULN), it was considered Abnormal. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results
|
3 participants
|
12 participants
|
3 participants
|
3 participants
|
6 participants
|
12 participants
|
PRIMARY outcome
Timeframe: Up to 28 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug
RP2D for BGB-A333 alone and in combination with tislelizumab was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 1800 mg.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=15 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1 A: Recommended Phase 2 Dose (RP2D) for BGB-333
|
—
|
—
|
1350 mg
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set (also used for efficacy analysis) included all participants who received at least 1 dose of study drug.
The ORR is defined as the percentage of participants who had confirmed Complete Response (CR) or Partial response (PR) assessed by investigator using RECIST version 1.1
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=12 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 2B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
|
—
|
—
|
41.7 Percentage of participants
Interval 15.17 to 72.33
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set included (also used for efficacy analysis) all participants who received at least 1 dose of study drug.
ORR is defined as the percentage of participants who had confirmed CR or PR assessed by investigator using RECIST version 1.1.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1A and Phase 1B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
|
33.3 Percentage of participants
Interval 0.84 to 90.57
|
16.7 Percentage of participants
Interval 2.09 to 48.41
|
0.0 Percentage of participants
Interval 0.0 to 70.76
|
33.3 Percentage of participants
Interval 0.84 to 90.57
|
50.0 Percentage of participants
Interval 11.81 to 88.19
|
—
|
SECONDARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set (also used for efficacy analysis) included all participants who received at least 1 dose of study drug.
DOR was defined as the time from the first determination of an objective response per RECIST version 1.1, until the first documentation of progression or death, whichever occurs first. DOR was not evaluable in Phase 1A and Phase 1B.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=5 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 2B: Duration of Response (DOR) Determined by Investigators Based on RECIST Version 1.1
|
—
|
—
|
9.6 Months
Interval 6.0 to
NA = Data not estimable due to insufficient number of participants with events
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
DCR is defined as the percentage of participants with best overall response of CR, PR and Stable Disease.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1 and Phase 2: Disease Control Rate (DCR) Determined by Investigators Based on RECIST Version 1.1
|
66.7 Percentage of participants
Interval 9.43 to 99.16
|
58.3 Percentage of participants
Interval 27.67 to 84.83
|
33.3 Percentage of participants
Interval 0.84 to 90.57
|
33.3 Percentage of participants
Interval 0.84 to 90.57
|
66.7 Percentage of participants
Interval 22.28 to 95.67
|
75.0 Percentage of participants
Interval 42.81 to 94.51
|
SECONDARY outcome
Timeframe: Up to 33.5 monthsPopulation: Safety Analysis Set included all participants who received at least 1 dose of study drug.
PFS was defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of disease progression assessed by investigator using RECIST v1.1 or death, whichever occurs first
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=12 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 2B: Progression-free Survival (PFS) Determined by Investigators Based on RECIST Version 1.1
|
—
|
—
|
6.1 Months
Interval 1.9 to 11.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21Population: The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s)
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B pharmacokinetic (PK) parameters were not estimated due to limited sampling.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1: Maximum Plasma Concentration (Cmax) of BGB-A333
|
594 μg/mL
Standard Deviation 150
|
455 μg/mL
Standard Deviation 127
|
167 μg/mL
Standard Deviation 42.4
|
351 μg/mL
Standard Deviation 151
|
466 μg/mL
Standard Deviation 91.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21Population: The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s)
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1: Time to Cmax (Tmax) of BGB-A333
|
0.06 Day
Interval 0.06 to 0.21
|
0.21 Day
Interval 0.05 to 0.22
|
0.05 Day
Interval 0.04 to 0.21
|
0.06 Day
Interval 0.05 to 0.06
|
0.05 Day
Interval 0.05 to 0.22
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21Population: The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s)
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1:Trough Serum Concentration (Ctrough) of BGB-A333
|
81.4 μg/mL
Standard Deviation 23.9
|
80.0 μg/mL
Standard Deviation 22.0
|
21.3 μg/mL
Standard Deviation 5.69
|
47.0 μg/mL
Standard Deviation 26.7
|
90.7 μg/mL
Standard Deviation 24.2
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21Population: The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s)
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. Actual observed time values for PK sampling, have an allowable time deviation (+/- 3 days) from the planned nominal time as pre-specified in the Visit Window section of the study protocol.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1: Time to Last Observed Concentration (Tlast) of BGB-A333
|
21.0 Day
Interval 21.0 to 24.0
|
21.0 Day
Interval 7.1 to 24.0
|
22.0 Day
Interval 21.0 to 22.0
|
21.0 Day
Interval 14.1 to 21.0
|
21.0 Day
Interval 14.0 to 22.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21Population: The PK analysis population includes all participants with valid PK sampling after treatment with study drug(s)
PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=11 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=2 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=5 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1: Area Under the Concentration-time Curve From 0 to 21 Days Post-dose (AUC 0-21day) of BGB-A333
|
4141 μg*day/mL
Standard Deviation 648
|
3546 μg*day/mL
Standard Deviation 814
|
1095 μg*day/mL
Standard Deviation 141
|
2913 μg*day/mL
Standard Deviation 320
|
3823 μg*day/mL
Standard Deviation 566
|
—
|
SECONDARY outcome
Timeframe: Up to 33.5 monthsPopulation: ADA analysis set included participants who received ≥ 1 dose of study drug(s), BGB-A333 in Phase 1A or BGB-A333 and tislelizumab in Phase 1B and Phase 2B and had ≥ 1 evaluable ADA result after treatment.
Treatment-emergent anti drug antibodies (ADA) was the sum of both treatment-induced ADA and treatment-boosted ADA, synonymous with "ADA Incidence."
Outcome measures
| Measure |
Phase 1A: BGB-A333 1800 mg
n=3 Participants
BGB-A333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=11 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 450 mg
n=3 Participants
BGB-A333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 Participants
BGB-A333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 1350 mg
n=6 Participants
BGB-A333 1350 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 Participants
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Phase 1A and Phase 2: Number of Participants With Detectable Treatment-Emergent Anti-BGB-A333 Antibodies
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
4 participants
|
Adverse Events
Phase 1A: BGB-A333 450 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 1A: BGB-A333 900 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 1A: BGB-333 1350 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 2 deaths
Phase 1A: BGB-333 1800 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
Serious events: 5 serious events
Other events: 12 other events
Deaths: 4 deaths
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Phase 1A: BGB-A333 450 mg
n=3 participants at risk
BGB-333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 participants at risk
BGB-333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-333 1350 mg
n=6 participants at risk
BGB-333 1350 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-333 1800 mg
n=3 participants at risk
BGB-333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 participants at risk
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 participants at risk
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
Other adverse events
| Measure |
Phase 1A: BGB-A333 450 mg
n=3 participants at risk
BGB-333 450 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-A333 900 mg
n=3 participants at risk
BGB-333 900 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-333 1350 mg
n=6 participants at risk
BGB-333 1350 mg, intravenously, every 3 weeks
|
Phase 1A: BGB-333 1800 mg
n=3 participants at risk
BGB-333 1800 mg, intravenously, every 3 weeks
|
Phase 1B: BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 participants at risk
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
Phase 2B (Urothelial Carcinoma Cohort): BGB-A333 1350 mg + Tislelizumab 200 mg
n=12 participants at risk
BGB-A333 1350 mg, intravenously, + Tislelizumab 200 mg, intravenously, every 3 weeks
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
4/12 • Number of events 4 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 4 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
50.0%
3/6 • Number of events 4 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
4/12 • Number of events 4 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
50.0%
3/6 • Number of events 3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
66.7%
2/3 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 5 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 7 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Fatigue
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
66.7%
2/3 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Asthenia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
25.0%
3/12 • Number of events 3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
2/6 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 9 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
25.0%
3/12 • Number of events 3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
25.0%
3/12 • Number of events 4 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
8.3%
1/12 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 2 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Reproductive system and breast disorders
Pelvic pain
|
33.3%
1/3 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
1/6 • Number of events 1 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/6 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/3 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
2/12 • Number of events 4 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/12 • From the date of consent until study termination (Approximately 33.5 months)
All adverse events were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights
- Publication restrictions are in place
Restriction type: OTHER