Trial Outcomes & Findings for A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours (NCT NCT02952248)
NCT ID: NCT02952248
Last Updated: 2026-01-27
Results Overview
Number of participants experiencing dose-limiting toxicities (DLTs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 / 5.0 observed in the first cycle (3 weeks) in order to meet the objective of assessment of the maximum tolerated dose (MTD) of ezabenlimab.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
110 participants
Primary outcome timeframe
Up to 3 weeks.
Results posted on
2026-01-27
Participant Flow
An open-label, multicentre, phase 1 trial in patients with advanced solid tumours. Phase Ia dose escalation part consists of 3 cohorts (80, 240 and 400 mg ezabenlimab) to determine the maximum tolerated dose, followed by Phase Ib dose expansion with 4 cohorts to further evaluate safety, pharmacokinetics and efficacy of ezabenlimab.
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participant milestones
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, 7 Tumours
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced and/or metastatic solid tumours including non-small cell lung cancer (NSCLC), bladder cancer, melanoma, gastric cancer, ovarian cancer, triple-negative breast cancer (TNBC), and renal cell carcinoma (RCC).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, High TMB
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with tumours that are tumour mutational burden (TMB)-high: any tumour with TMBhigh status (\>10 mutations/Mb), excluding those that are MSI-high (TMB and MSI status based on any validated test).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, Cervical/Anal/Skin
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with squamous cell cervical, anal, and skin tumours that are refractory to standard therapies.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
30
|
27
|
31
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
3
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
30
|
24
|
27
|
13
|
Reasons for withdrawal
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, 7 Tumours
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced and/or metastatic solid tumours including non-small cell lung cancer (NSCLC), bladder cancer, melanoma, gastric cancer, ovarian cancer, triple-negative breast cancer (TNBC), and renal cell carcinoma (RCC).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, High TMB
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with tumours that are tumour mutational burden (TMB)-high: any tumour with TMBhigh status (\>10 mutations/Mb), excluding those that are MSI-high (TMB and MSI status based on any validated test).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, Cervical/Anal/Skin
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with squamous cell cervical, anal, and skin tumours that are refractory to standard therapies.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
3
|
2
|
|
Overall Study
Progressive disease
|
3
|
3
|
3
|
27
|
20
|
22
|
9
|
|
Overall Study
Missed 2 cycles of treatment due to COVID-19
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Patient decision
|
0
|
0
|
0
|
1
|
3
|
1
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Clinical progression
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours
Baseline characteristics by cohort
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=3 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=3 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=3 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, 7 Tumours
n=30 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced and/or metastatic solid tumours including non-small cell lung cancer (NSCLC), bladder cancer, melanoma, gastric cancer, ovarian cancer, triple-negative breast cancer (TNBC), and renal cell carcinoma (RCC).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, High TMB
n=27 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with tumours that are tumour mutational burden (TMB)-high: any tumour with TMBhigh status (\>10 mutations/Mb), excluding those that are MSI-high (TMB and MSI status based on any validated test).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, Cervical/Anal/Skin
n=31 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with squamous cell cervical, anal, and skin tumours that are refractory to standard therapies.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=13 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.3 Years
STANDARD_DEVIATION 11.0 • n=25 Participants
|
58.3 Years
STANDARD_DEVIATION 23.8 • n=25 Participants
|
54.7 Years
STANDARD_DEVIATION 7.8 • n=50 Participants
|
64.8 Years
STANDARD_DEVIATION 12.6 • n=152 Participants
|
65.0 Years
STANDARD_DEVIATION 10.7 • n=614 Participants
|
52.5 Years
STANDARD_DEVIATION 13.0 • n=31 Participants
|
63.5 Years
STANDARD_DEVIATION 11.5 • n=120 Participants
|
60.6 Years
STANDARD_DEVIATION 13.2 • n=25 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
2 Participants
n=50 Participants
|
25 Participants
n=152 Participants
|
16 Participants
n=614 Participants
|
27 Participants
n=31 Participants
|
13 Participants
n=120 Participants
|
84 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=25 Participants
|
3 Participants
n=25 Participants
|
1 Participants
n=50 Participants
|
5 Participants
n=152 Participants
|
11 Participants
n=614 Participants
|
4 Participants
n=31 Participants
|
0 Participants
n=120 Participants
|
26 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=152 Participants
|
3 Participants
n=614 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=120 Participants
|
7 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=25 Participants
|
2 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
29 Participants
n=152 Participants
|
22 Participants
n=614 Participants
|
27 Participants
n=31 Participants
|
13 Participants
n=120 Participants
|
99 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
2 Participants
n=614 Participants
|
2 Participants
n=31 Participants
|
0 Participants
n=120 Participants
|
4 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=120 Participants
|
2 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
2 Participants
n=152 Participants
|
5 Participants
n=614 Participants
|
2 Participants
n=31 Participants
|
1 Participants
n=120 Participants
|
11 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=25 Participants
|
3 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
25 Participants
n=152 Participants
|
19 Participants
n=614 Participants
|
29 Participants
n=31 Participants
|
12 Participants
n=120 Participants
|
93 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=152 Participants
|
3 Participants
n=614 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=120 Participants
|
4 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=152 Participants
|
0 Participants
n=614 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: Up to 3 weeks.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ia dose escalation.
Number of participants experiencing dose-limiting toxicities (DLTs) graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 / 5.0 observed in the first cycle (3 weeks) in order to meet the objective of assessment of the maximum tolerated dose (MTD) of ezabenlimab.
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=3 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=3 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=3 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ia Dose Escalation: Number of Participants With Dose-limiting Toxicities (DLTs) in the First Cycle (3 Weeks)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From first infusion of study treatment until end of study treatment at the time of interim database lock plus 30 days, up to 853 days.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ib dose expansion.
Phase Ib dose expansion: Number of participants with dose-limiting toxicities (DLTs) during the entire treatment period
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=30 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=27 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=31 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=13 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ib Dose Expansion: Number of Participants With Dose-limiting Toxicities (DLTs) During the Entire Treatment Period
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first infusion of study treatment until end of study treatment at the time of interim database lock plus 30 days, up to 853 days.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ib dose expansion. Only participants with post baseline measurements were included in the analysis.
Confirmed objective Response (OR), defined as the best overall response of confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 assessed by the Investigator, where the best overall response is the best time point response recorded from the first administration of BI 754091 until the earliest of disease progression according to RECIST v1.1, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow- up or withdrawal of consent.
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=29 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=24 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=31 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=12 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ib Dose Expansion: Confirmed Objective Response (OR), Defined as the Best Overall Response of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 as Assessed by the Investigator
|
4 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From the first administration of BI 754091 until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow- up or withdrawal of consent, up to 511 days.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ia dose escalation.
Confirmed OR, defined as the best overall response of confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 as assessed by the Investigator where the best overall response is the best time point response recorded from the first administration of BI 754091 until the earliest of disease progression according to RECIST v1.1, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow- up or withdrawal of consent.
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=3 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=3 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=3 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ia Dose Escalation: Confirmed Objective Response According to RECIST v.1.1 as Assessed by the Investigator
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 5 minutes prior to BI 754091 infusion start and 0.5, 1, 1.5, 2, 4, 7, 24, 72, 168 and 336 hours after start of BI 754091 infusion.Population: Pharmacokinetic (PK) analysis set (PKS): The PKS included all patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Phase Ia dose escalation.
Maximum measured concentration (Cmax) of ezabenlimab in plasma after single or multiple dose administration of ezabenlimab. Results for cycle 1 and cycle 2 are reported.
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=3 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=3 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=3 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ia Dose Escalation: Maximum Measured Concentration (Cmax) of Ezabenlimab in Plasma
Cycle 1
|
25.3 Microgram/Milliliter
Geometric Coefficient of Variation 32.7
|
73.7 Microgram/Milliliter
Geometric Coefficient of Variation 9.93
|
128 Microgram/Milliliter
Geometric Coefficient of Variation 27.1
|
—
|
|
Phase Ia Dose Escalation: Maximum Measured Concentration (Cmax) of Ezabenlimab in Plasma
Cycle 2
|
33.3 Microgram/Milliliter
Geometric Coefficient of Variation 23.7
|
96.4 Microgram/Milliliter
Geometric Coefficient of Variation 18.3
|
144 Microgram/Milliliter
Geometric Coefficient of Variation 21.9
|
—
|
SECONDARY outcome
Timeframe: 5 minutes prior to BI 754091 infusion start and 0.5, 1, 1.5, 2, 4, 7, 24, 72, 168, 336 and 504 hours after start of BI 754091 infusion.Population: Pharmacokinetic (PK) analysis set (PKS): The PKS included all patients in the TS who provided at least one evaluable observation for at least one PK endpoint and no PK relevant protocol deviations. Phase Ia dose escalation. Only participants with non-missing values were included in the analysis.
Area under the Concentration-time curve of ezabenlimab in plasma over the time interval from 0 to 504 hours (AUC0-504) after single and multiple dose administrations of ezabenlimab. Results for cycle 1 and cycle 2 are reported.
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=3 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=3 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=3 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ia Dose Escalation: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504)
Cycle 1
|
4640 Microgram*hours/milliliter
Geometric Coefficient of Variation 28.0
|
14300 Microgram*hours/milliliter
Geometric Coefficient of Variation 19.6
|
22000 Microgram*hours/milliliter
Geometric Coefficient of Variation 31.9
|
—
|
|
Phase Ia Dose Escalation: Area Under the Concentration-time Curve of Ezabenlimab in Plasma Over the Time Interval From 0 to 504 Hours (AUC0-504)
Cycle 2
|
6790 Microgram*hours/milliliter
Geometric Coefficient of Variation 18.1
|
18800 Microgram*hours/milliliter
Geometric Coefficient of Variation 21.5
|
28500 Microgram*hours/milliliter
Geometric Coefficient of Variation 37.1
|
—
|
SECONDARY outcome
Timeframe: From first infusion of study treatment until the last infusion of study treatment plus 30 days, up to 511 days.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ia dose escalation.
Number of participants experiencing dose-limiting toxicities (DLTs), graded according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 / 5.0, from the start of treatment until end of treatment (in all cycles) as assessed approximately every 3 weeks.
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=3 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=3 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=3 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ia Dose Escalation: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) From the Start of Treatment Until End of Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From first BI 754091 infusion until disease progression or death, whichever is earlier up to 1668 days.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ib dose expansion.
Confirmed Progression-free survival (PFS) defined from date of start administration of BI 754091 to the date of disease progression according to RECIST v1.1 as assessed by the Investigator or death from any cause, whichever is earlier. PFS according to RECIST v1.1: For patients with 'event' as outcome for PFS: \- PFS \[days\] = date of outcome - date of first treatment administration + 1 For patients with 'censored' as outcome for PFS: \- PFS (censored) \[days\] = date of outcome - date of first treatment administration+ 1 Median progression free survival time in months is reported.
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=30 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=27 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=31 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=13 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ib Dose Expansion: Confirmed Progression-free Survival (PFS) Defined From Date of Start of Ezabenlimab to the Date of Disease Progression or Death, Whichever Was Earlier, According to RECIST v1.1 as Assessed by the Investigator
|
1.9 Months
Interval 1.2 to 3.3
|
2.7 Months
Interval 1.3 to
75th percentile could not be calculated because less than 75% of patients have not reached PFS.
|
2.6 Months
Interval 1.4 to 6.1
|
4.2 Months
Interval 1.4 to 5.5
|
SECONDARY outcome
Timeframe: From first infusion of study treatment until end of study treatment plus 30 days, up to 1668 days.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ib dose expansion.
Percentage of participants with adverse events (AEs)
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=30 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=27 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=31 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=13 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ib Dose Expansion: Percentage of Participants With Adverse Events (AEs)
|
96.7 Percentage of participants
|
96.3 Percentage of participants
|
96.8 Percentage of participants
|
100.0 Percentage of participants
|
SECONDARY outcome
Timeframe: From first infusion of study treatment until end of study treatment at the time of interim database lock plus 30 days, up to 853 days.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ib dose expansion.
Percentage of participants with serious adverse events (SAEs).
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=30 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=27 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=31 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=13 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ib Dose Expansion: Percentage of Participants With Serious Adverse Events (SAEs)
|
33.3 Percentage of participants
|
25.9 Percentage of participants
|
48.4 Percentage of participants
|
46.2 Percentage of participants
|
SECONDARY outcome
Timeframe: From first infusion of study treatment until end of study treatment plus 30 days, up to 1668 days.Population: Treated Set (TS): The TS included all participants who received at least 1 dose of ezabenlimab. Phase Ib dose expansion.
Percentage of participants with clinically relevant abnormalities in laboratory evaluations is reported by the percentage of participants with liver enzyme elevations. Abbreviations: ALT: Alanine aminotransferase ALP: Alkaline Phosphatase AST: Aspartate aminotransferase ULN: Upper limit of normal \*: Tbili elevation must be within +/- 30 days of ALT and/or AST elevation
Outcome measures
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=30 Participants
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=27 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=31 Participants
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=13 Participants
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|
|
Phase Ib Dose Expansion: Percentage of Participants With Clinically Relevant Abnormalities in Laboratory Evaluations
Maximum AST; >= 5x ULN and <10x ULN
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Phase Ib Dose Expansion: Percentage of Participants With Clinically Relevant Abnormalities in Laboratory Evaluations
Maximum ALP; >=3x ULN and <5x ULN
|
3.3 Percentage of participants
|
11.1 Percentage of participants
|
3.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Phase Ib Dose Expansion: Percentage of Participants With Clinically Relevant Abnormalities in Laboratory Evaluations
Maximum ALT; >= 3x ULN and <5x ULN
|
3.3 Percentage of participants
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Phase Ib Dose Expansion: Percentage of Participants With Clinically Relevant Abnormalities in Laboratory Evaluations
Maximum AST; >= 3x ULN and <5x ULN
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
0.0 Percentage of participants
|
7.7 Percentage of participants
|
|
Phase Ib Dose Expansion: Percentage of Participants With Clinically Relevant Abnormalities in Laboratory Evaluations
Maximum Total Bilirubin; >=2x ULN
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
3.2 Percentage of participants
|
0.0 Percentage of participants
|
|
Phase Ib Dose Expansion: Percentage of Participants With Clinically Relevant Abnormalities in Laboratory Evaluations
ALT and/or AST >= 3xULN and * total bilirubin >= 2xULN
|
0.0 Percentage of participants
|
3.7 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Phase Ib Dose Expansion: Percentage of Participants With Clinically Relevant Abnormalities in Laboratory Evaluations
Maximum ALP; >=5x ULN and <10x ULN
|
0.0 Percentage of participants
|
14.8 Percentage of participants
|
3.2 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
Phase Ia Dose Escalation: 80 mg Ezabenlimab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase Ia Dose Escalation: 240 mg Ezabenlimab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase Ia Dose Escalation: 400 mg Ezabenlimab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase Ib Dose Expansion: 240 mg Ezabenlimab, 7 Tumours
Serious events: 10 serious events
Other events: 27 other events
Deaths: 16 deaths
Phase Ib Dose Expansion: 240 mg Ezabenlimab, High TMB
Serious events: 9 serious events
Other events: 24 other events
Deaths: 10 deaths
Phase Ib Dose Expansion: 240 mg Ezabenlimab, Cervical/Anal/Skin
Serious events: 16 serious events
Other events: 30 other events
Deaths: 17 deaths
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
Serious events: 6 serious events
Other events: 13 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=3 participants at risk
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=3 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=3 participants at risk
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, 7 Tumours
n=30 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced and/or metastatic solid tumours including non-small cell lung cancer (NSCLC), bladder cancer, melanoma, gastric cancer, ovarian cancer, triple-negative breast cancer (TNBC), and renal cell carcinoma (RCC).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, High TMB
n=27 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with tumours that are tumour mutational burden (TMB)-high: any tumour with TMBhigh status (\>10 mutations/Mb), excluding those that are MSI-high (TMB and MSI status based on any validated test).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, Cervical/Anal/Skin
n=31 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with squamous cell cervical, anal, and skin tumours that are refractory to standard therapies.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=13 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Chest pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
COVID-19
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Spontaneous bacterial peritonitis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Troponin I increased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Renal and urinary disorders
Urogenital fistula
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous emphysema
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Surgical and medical procedures
Foot amputation
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Vascular disorders
Embolism
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
Other adverse events
| Measure |
Phase Ia Dose Escalation: 80 mg Ezabenlimab
n=3 participants at risk
80 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 240 mg Ezabenlimab
n=3 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ia Dose Escalation: 400 mg Ezabenlimab
n=3 participants at risk
400 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced solid tumours.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, 7 Tumours
n=30 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with advanced and/or metastatic solid tumours including non-small cell lung cancer (NSCLC), bladder cancer, melanoma, gastric cancer, ovarian cancer, triple-negative breast cancer (TNBC), and renal cell carcinoma (RCC).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, High TMB
n=27 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with tumours that are tumour mutational burden (TMB)-high: any tumour with TMBhigh status (\>10 mutations/Mb), excluding those that are MSI-high (TMB and MSI status based on any validated test).
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, Cervical/Anal/Skin
n=31 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with squamous cell cervical, anal, and skin tumours that are refractory to standard therapies.
|
Phase Ib Dose Expansion: 240 mg Ezabenlimab, VSCC
n=13 participants at risk
240 milligram (mg) ezabenlimab (BI 754091) solution for infusion after dilution (20mg/mL (vial with 15mL filling volume)) was administered as intravenous infusion on Day 1 of 21-day cycles in patients with recurrent human papillomavirus HPV-positive, or HPV-negative, vaginal or vulvar squamous cell carcinoma (VSCC).
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
9/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
22.6%
7/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
38.5%
5/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
23.1%
3/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
13.3%
4/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
12.9%
4/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.7%
5/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
18.5%
5/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.1%
5/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
13.3%
4/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
19.4%
6/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
38.5%
5/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.7%
5/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
18.5%
5/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.1%
5/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
30.0%
9/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
18.5%
5/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
29.0%
9/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
61.5%
8/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
10.0%
3/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
22.2%
6/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
12.9%
4/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Asthenia
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Chest pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Chills
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Fatigue
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
40.0%
12/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
22.2%
6/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
51.6%
16/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
38.5%
5/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Oedema peripheral
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
10.0%
3/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
25.8%
8/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
23.1%
3/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
12.9%
4/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
10.0%
3/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
19.4%
6/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
23.1%
3/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Candida infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
29.0%
9/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
30.8%
4/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
23.1%
3/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Blood creatine increased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Urine output decreased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
Weight decreased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.1%
5/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Investigations
White blood cell count increased
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
20.0%
6/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
18.5%
5/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
19.4%
6/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
30.8%
4/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
14.8%
4/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.1%
5/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.7%
5/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
19.4%
6/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
23.3%
7/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.1%
5/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
12.9%
4/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.7%
5/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
10.0%
3/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
12.9%
4/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
30.8%
4/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Pubic pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
13.3%
4/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
23.1%
3/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
12.9%
4/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Psychiatric disorders
Insomnia
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
22.6%
7/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Psychiatric disorders
Mental fatigue
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vaginal odour
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vulval ulceration
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
66.7%
2/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
20.0%
6/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
25.8%
8/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
23.1%
3/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
23.3%
7/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
16.1%
5/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
10.0%
3/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.7%
2/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
6.5%
2/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Itching scar
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
13.3%
4/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
9.7%
3/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
10.0%
3/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
11.1%
3/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
12.9%
4/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
15.4%
2/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
10.0%
3/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.7%
1/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Surgical and medical procedures
Cataract operation
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Vascular disorders
Hot flush
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
33.3%
1/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.3%
1/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.4%
2/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
3.2%
1/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Vascular disorders
Peripheral vein stenosis
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/3 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/30 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/27 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
0.00%
0/31 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
7.7%
1/13 • All-cause Mortality: From study start until end of study, up to 2444 days. Serious and other AEs: From treatment start until end of treatment, plus 30 days of residual effect period, up to 511 days for phase Ia dose escalation and up to 1668 days for phase Ib dose expansion.
Treated Set (TS): The TS included all patients who received at least 1 dose of ezabenlimab.
|
Additional Information
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Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
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Restriction type: OTHER