Trial Outcomes & Findings for Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) (NCT NCT03974022)
NCT ID: NCT03974022
Last Updated: 2026-01-29
Results Overview
To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
315 participants
Primary outcome timeframe
The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).
Results posted on
2026-01-29
Participant Flow
Participant milestones
| Measure |
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
|
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
3
|
7
|
6
|
10
|
14
|
14
|
7
|
31
|
0
|
5
|
7
|
91
|
111
|
|
Overall Study
COMPLETED
|
3
|
5
|
3
|
5
|
5
|
5
|
8
|
10
|
3
|
24
|
0
|
4
|
6
|
54
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
2
|
1
|
5
|
6
|
4
|
4
|
7
|
0
|
1
|
1
|
37
|
50
|
Reasons for withdrawal
| Measure |
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received sunvozertinib 50 mg once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
|
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
1
|
0
|
2
|
0
|
1
|
0
|
2
|
1
|
4
|
0
|
0
|
0
|
33
|
40
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
4
|
4
|
2
|
2
|
3
|
0
|
1
|
0
|
3
|
9
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
site terminated by sponsor or non compliance
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
Baseline characteristics by cohort
| Measure |
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=14 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=14 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=7 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=31 Participants
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=6 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=7 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=6 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
n=5 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
n=7 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
n=91 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
|
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
n=111 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
|
Total
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=12 Participants
|
62.5 years
n=4 Participants
|
60.5 years
n=5 Participants
|
64 years
n=4 Participants
|
61 years
n=528 Participants
|
—
|
48.0 years
n=35 Participants
|
62.0 years
n=4328 Participants
|
57.0 years
n=8687 Participants
|
64.0 years
n=153 Participants
|
63.5 years
n=200 Participants
|
44.0 years
n=32 Participants
|
65.0 years
n=26 Participants
|
62 years
n=35 Participants
|
64 years
n=35 Participants
|
62.0 years
n=32 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=12 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
3 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
3 Participants
n=153 Participants
|
4 Participants
n=200 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=26 Participants
|
61 Participants
n=35 Participants
|
63 Participants
n=35 Participants
|
186 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=12 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=35 Participants
|
3 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
4 Participants
n=153 Participants
|
2 Participants
n=200 Participants
|
1 Participants
n=32 Participants
|
1 Participants
n=26 Participants
|
30 Participants
n=35 Participants
|
48 Participants
n=35 Participants
|
129 Participants
n=32 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=12 Participants
|
9 Participants
n=4 Participants
|
13 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
23 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
2 Participants
n=35 Participants
|
5 Participants
n=4328 Participants
|
2 Participants
n=8687 Participants
|
5 Participants
n=153 Participants
|
3 Participants
n=200 Participants
|
1 Participants
n=32 Participants
|
0 Participants
n=26 Participants
|
59 Participants
n=35 Participants
|
65 Participants
n=35 Participants
|
204 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=35 Participants
|
3 Participants
n=32 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=12 Participants
|
5 Participants
n=4 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
1 Participants
n=8687 Participants
|
2 Participants
n=153 Participants
|
3 Participants
n=200 Participants
|
4 Participants
n=32 Participants
|
6 Participants
n=26 Participants
|
30 Participants
n=35 Participants
|
44 Participants
n=35 Participants
|
103 Participants
n=32 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=32 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=12 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=528 Participants
|
0 Participants
n=590 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
0 Participants
n=153 Participants
|
0 Participants
n=200 Participants
|
0 Participants
n=32 Participants
|
1 Participants
n=26 Participants
|
2 Participants
n=35 Participants
|
0 Participants
n=35 Participants
|
5 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: The DLT observation period is defined as the 28 days after the first multiple dose (up to 36 days from baseline).Population: Patients in part A Dose Escalation Cohorts who met either or both criteria below were included in DLT analysis: * Patients who received the single dose and at least 80% of planned doses of DZD9008 in the first 28-day of repeated dosing and completed minimum required safety evaluations. * Patients who had at least one DLT reported during the DLT period. 1 patient in 100 mg dose level and 1 patient in 300 mg dose level received less than 80% of planned dose were excluded.
To evaluate the safety and tolerability and defined the maximum tolerated dose (MTD) of sunvozertinib. DLT was evaluated in the DLT observation frame.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=5 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=6 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=6 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Dose Escalation: Dose Limiting Toxicities (DLTs).
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: through the study completion, an average of around 1 year for part BTo evaluate anti-tumor activity of Sunvozertinib in advanced NSCLC patients with EGFR Exon20 insertion at defined dose(s) by assessment of Objective Response Rate (ORR).
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=85 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=107 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Objective Response Rate (ORR) According to RECIST 1.1 by an Independent Review Committee (IRC).
|
—
|
45.9 percentage of participants
Interval 33.6 to 58.5
|
45.8 percentage of participants
Interval 34.8 to 57.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through the study completion, an average of around 1 year for part BTo assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=85 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=107 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR Using Investigators Assessments According to RECIST 1.1
confirmed DCR by IRC
|
—
|
89.4 percentage of participants
Interval 80.8 to 95.0
|
88.8 percentage of participants
Interval 81.2 to 94.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: DCR According to RECIST 1.1 Using Assessments Performed by an IRC; DCR Using Investigators Assessments According to RECIST 1.1
confirmed DCR by investigator
|
—
|
88.2 percentage of participants
Interval 79.4 to 94.2
|
88.8 percentage of participants
Interval 81.2 to 94.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through the study completion, an average of around 1 year for part BTo assess anti-tumor efficacy of Sunvozertinib using additional endpoints.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=85 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=107 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1
Median duration of response (IRC)
|
—
|
NA months
Interval 7.2 to
NA means Not Estimable due to data not mature (lack of events observed being lower than 50%)
|
NA months
Interval 6.7 to
NA means Not Estimable due to data not mature (lack of events observed being lower than 50%)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1
Median duration of response (investigator)
|
—
|
8.3 months
Interval 7.0 to
NA means Not Estimable due to data not mature (lack of events observed being lower than 50%)
|
8.8 months
Interval 5.3 to 18.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1
Median progression free survival (IRC)
|
—
|
8.4 months
Interval 6.8 to 11.2
|
6.9 months
Interval 5.6 to 11.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: DoR, PFS According to RECIST 1.1 Using Assessments Performed by an IRC; DoR, PFS Using Investigators Assessments According to RECIST 1.1
Median progression free survival (investigator)
|
—
|
8.3 months
Interval 5.5 to 10.9
|
6.8 months
Interval 5.5 to 8.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through the study completion, an average of around 1 year for part BPopulation: all patients had at least one dose of DZD9008
To determine the safety and tolerability of Sunvozertinib: Number of Participants With AEs, Number of Participants With SAEs. Using investigator reported AEs according to CTCAE and SAE criteria.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=91 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=111 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: AEs/SAEs
Any TEAE
|
—
|
91 participants
|
111 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AEs/SAEs
Any treatment- emergent SAE
|
—
|
37 participants
|
41 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.Population: Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.
To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. Confirmed ORR was defined as the percentage of patients achieving a CR (Complete Response) or PR (Partial Response) and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by a subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=6 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=7 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=5 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=13 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=14 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=5 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=29 Participants
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
n=5 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
n=7 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Confirmed ORR and DCR by Investigator.
Confirmed objective response rate
|
—
|
0 percentage of participants
Interval 0.0 to 70.8
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
0 percentage of participants
Interval 0.0 to 70.8
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
0 percentage of participants
Interval 0.0 to 52.2
|
50 percentage of participants
Interval 18.7 to 81.3
|
30.8 percentage of participants
Interval 9.1 to 61.4
|
21.4 percentage of participants
Interval 4.7 to 50.8
|
40.0 percentage of participants
Interval 5.3 to 85.3
|
55.2 percentage of participants
Interval 35.7 to 73.6
|
20.0 percentage of participants
Interval 0.5 to 71.6
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
|
Part A: Confirmed ORR and DCR by Investigator.
Confirmed disease control rate
|
—
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
50.0 percentage of participants
Interval 11.8 to 88.2
|
66.7 percentage of participants
Interval 9.4 to 99.2
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
80 percentage of participants
Interval 44.4 to 97.5
|
84.6 percentage of participants
Interval 54.6 to 98.1
|
92.9 percentage of participants
Interval 66.1 to 99.8
|
80.0 percentage of participants
Interval 28.4 to 99.5
|
93.1 percentage of participants
Interval 77.2 to 99.2
|
60.0 percentage of participants
Interval 14.7 to 94.7
|
85.7 percentage of participants
Interval 42.1 to 99.6
|
SECONDARY outcome
Timeframe: The maximum median of DoR was 19.3 months, and the maximum median of PFS was 12.5 months for part A.Population: Only participants in Part A were presented here, while Part B were presented separately. Participants in Part A with baseline and at least one post-treatment tumor assessment were included in this analysis.
To assess preliminary anti-tumor activity of sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator. DoR was presented for patients with confirmed objective response (CR or PR). DoR was the time from date of first documentation of CR or PR, which was subsequently confirmed, to date of first documentation of objective progression or death. Patients who had no documentation of objective progression or death was censored. PFS was the time from first dose date of sunvozertinib to date of first documentation of progression or death due to any cause, whichever occurred first. Patient who had no PFS event was censored.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=6 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=7 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=5 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=13 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=14 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=5 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=29 Participants
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
n=5 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
n=7 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: DoR and PFS by Investigator.
Median duration of response(month)
|
—
|
NA month
DoR cannot be calculated due to none achieved PR or CR.
|
4.0 month
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
NA month
DoR cannot be calculated due to none achieved PR or CR.
|
5.5 month
Interval 2.8 to 5.5
|
NA month
DoR cannot be calculated due to none achieved PR or CR.
|
NA month
Interval 3.2 to
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
4.2 month
Interval 3.2 to
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
6.3 month
Interval 2.8 to 23.4
|
4.3 month
Interval 3.0 to 5.6
|
9.8 month
Interval 5.6 to
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
19.3 month
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
5.6 month
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
|
Part A: DoR and PFS by Investigator.
Median progression free survival(month)
|
—
|
3.1 month
Interval 3.1 to 9.6
|
1.9 month
Interval 0.9 to 22.5
|
12.5 month
Interval 1.7 to
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
3.3 month
Interval 1.2 to 7.4
|
4.6 month
Interval 1.0 to 6.0
|
4.9 month
Interval 1.2 to
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
5.5 month
Interval 4.0 to 12.7
|
4.2 month
Interval 2.4 to 9.0
|
4.2 month
Interval 1.4 to
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
10.8 month
Interval 5.5 to 12.5
|
3.3 month
Interval 1.4 to 21.3
|
5.3 month
Interval 3.2 to
NA means "not estimable" due to the data not being mature (i.e., the number of observed events is lower than 50%).
|
SECONDARY outcome
Timeframe: The study duration was from the initiation of sunvozertinib treatment until the study completion. The median study duration was 10 months, and the maximal study duration was 51.4 months for part A.Population: Only participants in Part A were presented here, while Part B were presented separately. According to the clinical study protocol, only participants in Part A Dose Expansion Cohort 5 (treatment-naive patients) were evaluated by IRC. Therefore, we only present the IRC results from Part A Dose Expansion Cohort 5.
To retrospectively assess anti-tumor activity of sunvozertinib in treatment-naive NSCLC patients with EGFR Exon20ins according to RECIST 1.1 by IRC. Confirmed ORR was defined as the percentage of patients achieving a CR or PR and was confirmed by subsequent tumor assessment at least 4 weeks within the study period. Confirmed DCR was defined as the proportion of patients with a best overall response of CR, PR, or SD. Patients who achieved a CR or PR must be confirmed by subsequent tumor assessment at least 4 weeks within the study period. Patients who achieved a best overall response of SD must be confirmed by subsequent tumor assessment at least 35 days within the study period.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=29 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Confirmed ORR and DCR by Independent Review Committee (IRC).
Confirmed objective response rate
|
—
|
62.1 percentage of participants
Interval 42.3 to 79.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Confirmed ORR and DCR by Independent Review Committee (IRC).
Confirmed disease control rate
|
—
|
89.7 percentage of participants
Interval 72.6 to 97.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 0 Day 1: 0 (predose) up to 168 hours (for Part A escalation); Cycle 1 Day 1: 0 (predose) up to 24 hours (for Part A expansion)Population: All participants who have received at least one dose of study drug with at least one measurable plasma concentration of DZD9008 post dose without any important deviations or events that would exclude the participants.
Maximum observed plasma concentration (ng/mL), obtained directly from the observed concentration versus time data. Calculated for the single dose.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=6 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=2 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=7 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=4 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=13 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=7 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=29 Participants
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Dose Escalation and Expansion: Maximum Plasma Concentration (Cmax) of DZD9008
|
—
|
38.95 ng/mL
Geometric Coefficient of Variation 37.3
|
89.19 ng/mL
Geometric Coefficient of Variation 53.5
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculable, insufficient number of participants for calculation after excluding the data impacted by prohibited medication co-administration.
|
428.8 ng/mL
Geometric Coefficient of Variation 69.2
|
167.8 ng/mL
Geometric Coefficient of Variation 90.7
|
176.3 ng/mL
Geometric Coefficient of Variation 50.7
|
286.7 ng/mL
Geometric Coefficient of Variation 62.6
|
253.0 ng/mL
Geometric Coefficient of Variation 44.1
|
346.5 ng/mL
Geometric Coefficient of Variation 33.5
|
354.3 ng/mL
Geometric Coefficient of Variation 68.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 0 Day 1: 0 (predose) up to 168 hours (for Part A escalation); Cycle 1 Day 1: 0 (predose) up to 24 hours (for Part A expansion)Population: All participants who have received at least one dose of study drug with at least one measurable plasma concentration of DZD9008 post dose without any important deviations or events that would exclude the participants.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=6 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=2 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=7 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=4 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=13 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=7 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=29 Participants
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Dose Escalation and Expansion: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008
|
—
|
1434 h*ng/mL
Geometric Coefficient of Variation 45.9
|
2693 h*ng/mL
Geometric Coefficient of Variation 115.8
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Not calculable, insufficient number of participants for calculation after excluding the data impacted by prohibited medication co-administration.
|
12540 h*ng/mL
Geometric Coefficient of Variation 69.7
|
6419 h*ng/mL
Geometric Coefficient of Variation 60.0
|
2300 h*ng/mL
Geometric Coefficient of Variation 46.0
|
3800 h*ng/mL
Geometric Coefficient of Variation 56.9
|
3313 h*ng/mL
Geometric Coefficient of Variation 39.3
|
4517 h*ng/mL
Geometric Coefficient of Variation 28.2
|
4338 h*ng/mL
Geometric Coefficient of Variation 60.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose expansion and expansion)Population: All participants who have received at least one dose of study drug with at least one measurable plasma concentration of DZD9008 post dose without any important deviations or events that would exclude the participants.
Maximum observed plasma concentration(ng/mL), at steady state, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=5 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=2 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=9 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=9 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=4 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=19 Participants
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Dose Escalation and Expansion: Cmax,ss, at Steady State of DZD9008
|
—
|
82.85 ng/mL
Geometric Coefficient of Variation 17.2
|
229.4 ng/mL
Geometric Coefficient of Variation 50.6
|
NA ng/mL
Geometric Coefficient of Variation NA
Not calculable, insufficient number of participants for calculation after excluding the data impacted by prohibited medication co-administration.
|
590.2 ng/mL
Geometric Coefficient of Variation 80.9
|
677.0 ng/mL
Geometric Coefficient of Variation 21.9
|
358.0 ng/mL
Geometric Coefficient of Variation 53.4
|
717.5 ng/mL
Geometric Coefficient of Variation 40.9
|
613.3 ng/mL
Geometric Coefficient of Variation 48.8
|
819.3 ng/mL
Geometric Coefficient of Variation 57.3
|
716.5 ng/mL
Geometric Coefficient of Variation 41.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: 0 (predose) up to 24 hours (for Part A Dose escalation and expansion)Population: All participants who have received at least one dose of study drug with at least one measurable plasma concentration of DZD9008 post dose without any important deviations or events that would exclude the participants.
Area under the plasma concentration-time curve in the dose interval at steady state, calculated by the linear up/log down rule.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=5 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=2 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=3 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=9 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=10 Participants
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=9 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=4 Participants
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=19 Participants
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Dose Escalation and Expansion: AUCss, at Steady State of DZD9008
|
—
|
1506 h*ng/mL
Geometric Coefficient of Variation 13.2
|
3823 h*ng/mL
Geometric Coefficient of Variation 55.6
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Not calculable, insufficient number of participants for calculation after excluding the data impacted by prohibited medication co-administration.
|
10240 h*ng/mL
Geometric Coefficient of Variation 78.1
|
12030 h*ng/mL
Geometric Coefficient of Variation 25.2
|
5906 h*ng/mL
Geometric Coefficient of Variation 52.3
|
11630 h*ng/mL
Geometric Coefficient of Variation 40.3
|
9949 h*ng/mL
Geometric Coefficient of Variation 45.8
|
14170 h*ng/mL
Geometric Coefficient of Variation 47.9
|
12030 h*ng/mL
Geometric Coefficient of Variation 40.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 9: 0 (predose) up to 168 hours.Population: All participants from the food effect cohort for whom a PK profile is available on at least one of the fed and fasted dosing days.
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose, in the fasted or fed state.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=12 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Food Effect: Maximum Plasma Concentration (Cmax) of DZD9008
Part A Food effect: Maximum Plasma Concentration (Cmax) of DZD9008 under Fasted condition
|
—
|
307.0 ng/mL
Geometric Coefficient of Variation 59.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A Food Effect: Maximum Plasma Concentration (Cmax) of DZD9008
Part A Food effect: Maximum Plasma Concentration (Cmax) of DZD9008 under High-Fat Meal condition
|
—
|
331.6 ng/mL
Geometric Coefficient of Variation 48.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 9: 0 (predose) up to 168 hours.Population: All participants from the food effect cohort for whom a PK profile is available on at least one of the fed and fasted dosing days.
Area under the plasma concentration-time-curve from time zero the last quantifiable time point, calculated by the linear up/log down rule, in the fasted or fed state.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=12 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A Food Effect: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008
Part A Food effect: AUC0-t of DZD9008 under Fasted condition
|
—
|
8266 h*ng/mL
Geometric Coefficient of Variation 65.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A Food Effect: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008
Part A Food effect: AUC0-t of DZD9008 under High-Fat Meal condition
|
—
|
10050 h*ng/mL
Geometric Coefficient of Variation 67.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0 (predose) up to 24 hoursPopulation: All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the single dose.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=22 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=21 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Maximum Plasma Concentration (Cmax) of DZD9008 and DZ0753
Part B: Maximum Plasma Concentration (Cmax) of DZD9008
|
—
|
173.4 ng/mL
Geometric Coefficient of Variation 80.4
|
325.8 ng/mL
Geometric Coefficient of Variation 73.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Maximum Plasma Concentration (Cmax) of DZD9008 and DZ0753
Part B: Maximum Plasma Concentration (Cmax) of DZ0753
|
—
|
18.90 ng/mL
Geometric Coefficient of Variation 113.4
|
40.40 ng/mL
Geometric Coefficient of Variation 78.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: 0 (predose) up to 24 hoursPopulation: All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.
Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear up/log down rule.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=22 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=21 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008 and DZ0753.
Part B: AUC0-t of DZD9008
|
—
|
2423 h*ng/mL
Geometric Coefficient of Variation 71.9
|
4397 h*ng/mL
Geometric Coefficient of Variation 55.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Area Under the Plasma Concentration-time Curve From Zero to the Last Measurable Concentration (AUC0-t) of DZD9008 and DZ0753.
Part B: AUC0-t of DZ0753
|
—
|
200.4 h*ng/mL
Geometric Coefficient of Variation 125.2
|
448.5 h*ng/mL
Geometric Coefficient of Variation 69.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: 0 (predose) up to 24 hoursPopulation: All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.
Maximum observed plasma concentration, obtained directly from the observed concentration versus time data. Calculated for the multiple dose.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=14 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=9 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Cmax,ss, at Steady State of DZD9008 and DZ0753
Part B: Maximum Plasma Concentration (Cmax,ss) of DZD9008
|
—
|
342.8 ng/mL
Geometric Coefficient of Variation 57.4
|
642.3 ng/mL
Geometric Coefficient of Variation 48.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Cmax,ss, at Steady State of DZD9008 and DZ0753
Part B: Maximum Plasma Concentration (Cmax,ss) of DZ0753
|
—
|
42.58 ng/mL
Geometric Coefficient of Variation 108.0
|
112.4 ng/mL
Geometric Coefficient of Variation 83.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: 0 (predose) up to 24 hoursPopulation: All dosed participants who have at least one measurable plasma concentration of DZD9008 post dose with no protocol deviations or adverse event thought to impact the analysis of the PK data.
Area under the plasma concentration-time curve from time zero in the dose interval at steady state, calculated by the linear up/log down rule.
Outcome measures
| Measure |
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=14 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=9 Participants
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: AUCss, at Steady State of DZD9008 and DZ0753.
Part B: AUCss, at Steady State of DZD9008
|
—
|
6286 h*ng/mL
Geometric Coefficient of Variation 56.1
|
10230 h*ng/mL
Geometric Coefficient of Variation 47.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: AUCss, at Steady State of DZD9008 and DZ0753.
Part B: AUCss, at Steady State of DZ0753
|
—
|
728.9 h*ng/mL
Geometric Coefficient of Variation 112.2
|
1722 h*ng/mL
Geometric Coefficient of Variation 84.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
Serious events: 4 serious events
Other events: 10 other events
Deaths: 1 deaths
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
Serious events: 9 serious events
Other events: 14 other events
Deaths: 2 deaths
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
Serious events: 2 serious events
Other events: 7 other events
Deaths: 1 deaths
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
Serious events: 14 serious events
Other events: 31 other events
Deaths: 4 deaths
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
Serious events: 37 serious events
Other events: 91 other events
Deaths: 33 deaths
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
Serious events: 41 serious events
Other events: 111 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=6 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=3 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=7 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=6 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=10 participants at risk
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=14 participants at risk
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=14 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=7 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=31 participants at risk
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
n=5 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
n=7 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
n=91 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
|
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
n=111 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Blue toe syndrome
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Anisocoria
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
8.1%
9/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Pancreatic enzyme abnormality
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Death
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
General physical health deterioration
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Hepatobiliary disorders
Suspected drug-induced liver injury
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Device related infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Hepatitis B reactivation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.6%
6/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Suspected COVID-19
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm benign
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
Other adverse events
| Measure |
Part A Dose Escalation Cohort 1: Sunvozertinib 50 mg
n=3 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 50 mg sunvozertinib, followed by a 7-day washout period. Then, they received 50 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 2: Sunvozertinib 100 mg
n=6 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 100 mg sunvozertinib, followed by a 7-day washout period. Then, they received 100 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 3: Sunvozertinib 200 mg
n=3 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 200 mg sunvozertinib, followed by a 7-day washout period. Then, they received 200 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 4: Sunvozertinib 300 mg
n=7 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 300 mg sunvozertinib, followed by a 7-day washout period. Then, they received 300 mg sunvozertinib once daily continuously.
|
Part A Dose Escalation Cohort 5: Sunvozertinib 400 mg
n=6 participants at risk
Patients with EGFR or HER2 mutations, previously treated with at least one line of systemic therapy.
Patients received a single dose of 400 mg sunvozertinib, followed by a 7-day washout period. Then, they received 400 mg sunvozertinib once daily continuously.
|
Part A Dose Expansion Cohort 1: Sunvozertinib 200 mg, Dosing in the Fasted State
n=10 participants at risk
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 2: Sunvozertinib 300 mg, Dosing in the Fasted State
n=14 participants at risk
Patients with EGFR or HER2 exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing in the fasted state continuously.
|
Part A Dose Expansion Cohort 3: Sunvozertinib 200 mg; Dosing With a Low-fat Meal
n=14 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 200 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 4: Sunvozertinib 300 mg; Dosing With a Low-fat Meal
n=7 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 5: Treatment naïve, Sunvozertinib 300 mg, Dosing With a Low-fat Meal
n=31 participants at risk
Patients with EGFR exon20ins, treatment naïve. Patients received sunvozertinib 300 mg once daily dosing with a low-fat meal continuously.
|
Part A Dose Expansion Cohort 6: Previously Treated With Amivantamab; Sunvozertinib 300 mg
Patients with EGFR exon20ins, were refractory to, relapsed from, or intolerant to previous amivantamab treatment.
No patient was enrolled into this cohort.
|
Part A Food Effect Cohort 1: Sunvozertinib 300 mg; High-Fat Meal Condition First, Then Fasted
n=5 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part A Food Effect Cohort 2: Sunvozertinib 300 mg; Fasted Condition First, Then High-Fat Meal
n=7 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized at a 1:1 ratio to receive a single dose of sunvozertinib 300 mg under the Fasted condition, followed by a 7-day washout and crossed to receive a single dose of sunvozertinib 300 mg under the High-Fat Meal condition, followed by a 7-day washout. Then patients received sunvozertinib 300 mg once daily continuously.
|
Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg
n=91 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 200 mg once daily continuously.
|
Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg
n=111 participants at risk
Patients with EGFR exon20ins, previously treated with at least one line of systemic therapy.
Patients were randomized to receive sunvozertinib 300 mg once daily continuously.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
2/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
35.7%
5/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
22.6%
7/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
45.1%
41/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
47.7%
53/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.1%
11/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.6%
4/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.6%
6/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.6%
6/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.6%
4/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Blepharitis
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Keratitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Presbyopia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.6%
6/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Visual impairment
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Vitreous floaters
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
13/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.4%
16/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
17.6%
16/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.8%
22/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.2%
8/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
66.7%
2/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
2/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
35.7%
5/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
22.6%
7/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
27.5%
25/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.4%
16/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
66.7%
2/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
57.1%
4/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
83.3%
5/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
70.0%
7/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
85.7%
12/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
85.7%
12/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
100.0%
7/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
80.6%
25/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
60.0%
3/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
71.4%
5/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
71.4%
65/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
84.7%
94/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.7%
7/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.6%
4/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.0%
10/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
35.7%
5/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.1%
11/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.8%
12/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
3/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
2/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
7/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
6/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.1%
5/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
80.0%
4/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
57.1%
4/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
30.8%
28/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
43.2%
48/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
2/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
4/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
57.1%
4/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
32.3%
10/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.8%
18/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.8%
22/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
83.3%
5/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
6/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
22.6%
7/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
35.2%
32/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
44.1%
49/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
13/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
27.0%
30/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Catheter site pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Chills
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Fatigue
|
66.7%
2/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
3/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
6/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.1%
5/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
26.4%
24/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.8%
22/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Generalised oedema
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Localised oedema
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Malaise
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
11.0%
10/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.6%
4/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.6%
14/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.1%
5/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.7%
7/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.0%
10/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
30.0%
3/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
57.1%
4/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.7%
7/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.2%
8/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
General disorders
Swelling
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Bacterial colitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.9%
9/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
13.5%
15/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Ear infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Nail infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Paronychia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
4/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
6/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
7/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
54.8%
17/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
26/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
38.7%
43/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
8.1%
9/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Rash pustular
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.9%
9/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.6%
4/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.9%
4/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
22.0%
20/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.2%
18/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Infections and infestations
Wound infection
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.6%
4/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Ear injury
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Amylase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
57.1%
4/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.4%
6/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
17.6%
16/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.2%
18/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.9%
4/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
13.2%
12/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
15.3%
17/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.1%
5/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.8%
18/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
17.1%
19/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.7%
7/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
45.2%
14/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
38.5%
35/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
53.2%
59/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
3/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
57.1%
4/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.1%
5/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
26/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
31.5%
35/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.7%
7/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.9%
11/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Blood urea increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Fluid balance negative
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Fluid balance positive
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.4%
6/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
23.1%
21/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
15.3%
17/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Lung diffusion test decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.1%
11/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.0%
10/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
13.2%
12/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.4%
16/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Platelet count decreased
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.8%
12/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
3/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
25.3%
23/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
25.2%
28/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
13.2%
12/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.9%
11/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
3/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
4/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
35.7%
5/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
57.1%
4/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
35.5%
11/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
48.4%
44/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.5%
45/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.6%
6/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.9%
9/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
8.8%
8/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.9%
11/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
15.4%
14/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.0%
10/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
4/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.9%
19/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.8%
22/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.6%
6/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.6%
4/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.7%
7/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.9%
11/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.9%
4/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
8.8%
8/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.1%
5/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.1%
5/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Dementia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.6%
6/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.0%
10/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
35.7%
5/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
8.8%
8/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
15.3%
17/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Meige's syndrome
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Seizure
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
2/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.1%
11/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Reproductive system and breast disorders
Penis disorder
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
2/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.9%
4/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
15.3%
17/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
22.6%
7/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.9%
11/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
35.7%
5/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
13.2%
12/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
13.5%
15/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.4%
4/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
12.9%
4/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.7%
7/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.5%
2/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.3%
7/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
66.7%
2/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
22.6%
7/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.7%
7/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.2%
8/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
2/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
2/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
4/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
4/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
25.8%
8/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.9%
19/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
26.1%
29/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.6%
4/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.2%
8/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.90%
1/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
4/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
19.4%
6/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
26.4%
24/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
23.4%
26/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Purpura senile
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
66.7%
2/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
3/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
4/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
6/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
51.6%
16/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
37.4%
34/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
46.8%
52/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.8%
2/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
50.0%
5/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
21.4%
3/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
28.6%
4/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
42.9%
3/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
22.6%
7/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
40.0%
2/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
6.6%
6/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
4.5%
5/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
9.7%
3/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.4%
6/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.2%
1/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
1.1%
1/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Cyanosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.2%
2/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
16.7%
1/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
1/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
33.3%
2/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
10.0%
1/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
2/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
20.0%
1/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
5.5%
5/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
57.1%
4/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
14.3%
1/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
3.3%
3/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
2.7%
3/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/3 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/6 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/10 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
7.1%
1/14 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/31 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
—
0/0 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/5 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/7 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/91 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
0.00%
0/111 • Survival data continued to be collected for Part B participants following treatment discontinuation. SAEs and other AEs were monitored from the study treatment until the end of treatment, an average of approximately 11 months.
No patient was enrolled in Part A dose expansion cohort 6 due to conflict with enrollment of Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators, who are not employed by the sponsor, are free to publish study results. They must submit a copy of their publication to the sponsor for review at least 30 days in advance for manuscripts and 7 days for abstracts. The sponsor may request the removal of confidential information, identify patentable inventions, and provide comments. Publication may be delayed for up to 60 days to allow for a patent application. After this period, investigators can proceed with publication.
- Publication restrictions are in place
Restriction type: OTHER