Platform Trial Evaluating Safety and Efficacy of Ezabenlimab Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours
CompletedPhase 2Results postedLast updated 27 January 2026
What this trial tests
Phase 2 trial testing Ezabenlimab in Neoplasm Metastasis in 211 participants. Completed in 3 December 2024.
18 and older, any sex, with Neoplasm Metastasis or Advanced Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
[Module C] Duration of Response (DoR)Secondary· From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 174.6 weeks.
Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on
Group
Value
95% CI
Module C, Cohort 1: GEC Patients
105.95
12.3 – 174.6
Module C, Cohort 2: 2ary Resistance Patients
30.90
6.4 – 81.3
Module C, Cohort 3: 1ary Resistance Patients
8.50
8.4 – 8.6
Module C, Cohort 4: CRC Patients
25.00
12.1 – 37.9
Module C, Cohort 5: EC Patients
47.30
6.1 – 143.1
[Module C] Disease Control (DC)Secondary· From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD)
Group
Value
95% CI
Module C, Cohort 1: GEC Patients
57.1
37.2 – 75.5
Module C, Cohort 2: 2ary Resistance Patients
73.3
54.1 – 87.7
Module C, Cohort 3: 1ary Resistance Patients
42.9
24.5 – 62.8
Module C, Cohort 4: CRC Patients
56.7
37.4 – 74.5
Module C, Cohort 5: EC Patients
77.8
52.4 – 93.6
[Module C] Disease Control (DC) - Bayesian Hierarchical ModelSecondary· From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pro
Group
Value
95% CI
Module C, Cohort 1: GEC Patients
NA
NA – NA
Module C, Cohort 2: 2ary Resistance Patients
NA
NA – NA
Module C, Cohort 3: 1ary Resistance Patients
NA
NA – NA
Module C, Cohort 4: CRC Patients
NA
NA – NA
Module C, Cohort 5: EC Patients
NA
NA – NA
[Module C] Progression-free Survival (PFS)Secondary· From first drug administration until PD or death, whichever occurred earlier. Up to approximately 186.1 weeks.
Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation.
Group
Value
95% CI
Module C, Cohort 1: GEC Patients
13.4
6.1 – 33.7
Module C, Cohort 2: 2ary Resistance Patients
29.1
13.0 – 48.7
Module C, Cohort 3: 1ary Resistance Patients
6.1
5.7 – 12.1
Module C, Cohort 4: CRC Patients
12.6
6.1 – 23.6
Module C, Cohort 5: EC Patients
75.0
24.9 – NA
[Module A] Duration of Response (DoR)Secondary· From first documented CR or PR (RECIST v1.1) until the earlier of disease progression or death. Up to 63.6 weeks.
Duration of response (DoR) was defined as the time from first documented complete response (CR) or partial response (PR) (RECIST v1.1) among patients with objective response (OR), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. DoR parameters were calculated based on Kaplan-Meier estimation. The analysis was performed on
Group
Value
95% CI
Module A, Cohort 2: 2ary Resistance Patients
12.30
5.7 – 31.4
Module A, Cohort 3: 1ary Resistance Patients
28.30
0.1 – 63.6
[Module A] Disease Control (DC)Secondary· From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
Disease Control (DC) defined as the percentage of patients with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD)
Group
Value
95% CI
Module A, Cohort 1: GEC Patients
0
0.0 – 84.2
Module A, Cohort 2: 2ary Resistance Patients
42.4
25.5 – 60.8
Module A, Cohort 3: 1ary Resistance Patients
45.2
29.8 – 61.3
[Module A] Disease Control (DC) - Bayesian Hierarchical ModelSecondary· From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
Disease Control (DC), defined as the disease control rate (DCR) of participants with best overall response of complete response (CR), partial response (PR), or stable disease (SD), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). CR was defined as the disappearance of all target lesions, PR was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for pro
Group
Value
95% CI
Module A, Cohort 1: GEC Patients
NA
NA – NA
Module A, Cohort 2: 2ary Resistance Patients
NA
NA – NA
Module A, Cohort 3: 1ary Resistance Patients
NA
NA – NA
[Module A] Progression-free Survival (PFS)Secondary· From first drug administration until PD, death, or cut-off date of July 2021, whichever occurred earlier. Up to approximately 104.7 weeks.
Progression-free survival (PFS) was defined as the time from first treatment administration until progressive disease (PD), according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1), or death from any cause, whichever occurred earlier. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. PFS parameters were calculated based on Kaplan-Meier estimation. Progression free survival was collected, according to the clinical trial protocol until July 2021.
Group
Value
95% CI
Module A, Cohort 1: GEC Patients
5.9
5.7 – NA
Module A, Cohort 2: 2ary Resistance Patients
6.7
5.9 – 11.9
Module A, Cohort 3: 1ary Resistance Patients
8.9
5.7 – 16.9
[Module C] Objective Response (OR)Primary· From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
Group
Value
95% CI
Module C, Cohort 1: GEC Patients
14.3
4.0 – 32.7
Module C, Cohort 2: 2ary Resistance Patients
23.3
9.9 – 42.3
Module C, Cohort 3: 1ary Resistance Patients
0.0
0.0 – 12.3
Module C, Cohort 4: CRC Patients
3.3
0.1 – 17.2
Module C, Cohort 5: EC Patients
44.4
21.5 – 69.2
[Module C] Objective Response (OR) - Bayesian Hierarchical ModelPrimary· From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 188.3 weeks.
Confirmed objective response (OR), defined as the objective response rate (ORR) of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The estimated objective response rate is presented by the posterior med
Group
Value
95% CI
Module C, Cohort 1: GEC Patients
NA
NA – NA
Module C, Cohort 2: 2ary Resistance Patients
NA
NA – NA
Module C, Cohort 3: 1ary Resistance Patients
NA
NA – NA
Module C, Cohort 4: CRC Patients
NA
NA – NA
Module C, Cohort 5: EC Patients
NA
NA – NA
[Module A] Objective Response (OR)Primary· From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
Confirmed objective response (OR), defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference.
Group
Value
95% CI
Module A, Cohort 1: GEC Patients
0.0
0.0 – 84.2
Module A, Cohort 2: 2ary Resistance Patients
6.1
0.7 – 20.2
Module A, Cohort 3: 1ary Resistance Patients
9.5
2.7 – 22.6
[Module A] Objective Response (OR) - Bayesian Hierarchical ModelPrimary· From first drug administration until the earliest of disease progression, death or last evaluable tumor assessment before start of subsequent anti-cancer therapy. Up to approximately 152.4 weeks.
Confirmed objective response (OR), defined as the objective response rate (ORR) of participants with best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1 (v1.1). Complete response (CR) was defined as the disappearance of all target lesions and partial response (PR) was defined as decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The estimated objective response rate is presented by the posterior med
Group
Value
95% CI
Module A, Cohort 1: GEC Patients
NA
NA – NA
Module A, Cohort 2: 2ary Resistance Patients
NA
NA – NA
Module A, Cohort 3: 1ary Resistance Patients
NA
NA – NA
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event reporting and all-cause mortality: From first until last drug administration plus residual effect period (30 days). Up to approximately 192.6 weeks for module C and approximately 156.7 weeks for module A..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Module C, Cohort 1: GEC Patients
Serious: 11/28 (39%)
Deaths: 24/28
Module C, Cohort 2: 2ary Resistance Patients
Serious: 18/30 (60%)
Deaths: 20/30
Module C, Cohort 3: 1ary Resistance Patients
Serious: 12/28 (43%)
Deaths: 22/28
Module C, Cohort 4: CRC Patients
Serious: 13/30 (43%)
Deaths: 17/30
Module C, Cohort 5: EC Patients
Serious: 11/18 (61%)
Deaths: 4/18
Module A, Cohort 1: GEC Patients
Serious: 1/2 (50%)
Deaths: 0/2
Module A, Cohort 2: 2ary Resistance Patients
Serious: 13/33 (39%)
Deaths: 29/33
Module A, Cohort 3: 1ary Resistance Patients
Serious: 12/42 (29%)
Deaths: 32/42
Serious adverse events (105 terms)
Reaction
System
Module C, Cohort 1: GEC Pa…
Module C, Cohort 2: 2ary R…
Module C, Cohort 3: 1ary R…
Module C, Cohort 4: CRC Pa…
Module C, Cohort 5: EC Pat…
Module A, Cohort 1: GEC Pa…
Module A, Cohort 2: 2ary R…
Module A, Cohort 3: 1ary R…
DEEP VEIN THROMBOSIS
VASCULAR DISORDERS
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ASCITES
GASTROINTESTINAL DISORDERS
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OESOPHAGEAL PERFORATION
GASTROINTESTINAL DISORDERS
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SMALL INTESTINAL OBSTRUCTION
GASTROINTESTINAL DISORDERS
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PAIN
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
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PNEUMONIA ASPIRATION
INFECTIONS AND INFESTATIONS
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URINARY TRACT INFECTION
INFECTIONS AND INFESTATIONS
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FALL
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
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ASPIRATION
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
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PLEURAL EFFUSION
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
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PNEUMOTHORAX
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
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HYPERTENSION
VASCULAR DISORDERS
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ANAEMIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
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BANDAEMIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
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IMMUNE THROMBOCYTOPENIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
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NEUTROPENIA
BLOOD AND LYMPHATIC SYSTEM DISORDERS
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ACUTE LEFT VENTRICULAR FAILURE
CARDIAC DISORDERS
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ACUTE MYOCARDIAL INFARCTION
CARDIAC DISORDERS
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ATRIAL FIBRILLATION
CARDIAC DISORDERS
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ATRIOVENTRICULAR BLOCK COMPLETE
CARDIAC DISORDERS
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CARDIAC ARREST
CARDIAC DISORDERS
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MYOCARDITIS
CARDIAC DISORDERS
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PERICARDIAL EFFUSION
CARDIAC DISORDERS
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SUPRAVENTRICULAR TACHYCARDIA
CARDIAC DISORDERS
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ADRENAL INSUFFICIENCY
ENDOCRINE DISORDERS
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Other adverse events (153 terms — click to expand)
Reaction
System
Module C, Cohort 1: GEC Pa…
Module C, Cohort 2: 2ary R…
Module C, Cohort 3: 1ary R…
Module C, Cohort 4: CRC Pa…
Module C, Cohort 5: EC Pat…
Module A, Cohort 1: GEC Pa…
Module A, Cohort 2: 2ary R…
Module A, Cohort 3: 1ary R…
FATIGUE
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
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WEIGHT DECREASED
INVESTIGATIONS
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NAUSEA
GASTROINTESTINAL DISORDERS
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OEDEMA PERIPHERAL
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
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CONSTIPATION
GASTROINTESTINAL DISORDERS
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VOMITING
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COUGH
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
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DIARRHOEA
GASTROINTESTINAL DISORDERS
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DECREASED APPETITE
METABOLISM AND NUTRITION DISORDERS
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HYPERTENSION
VASCULAR DISORDERS
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ABDOMINAL PAIN
GASTROINTESTINAL DISORDERS
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ARTHRALGIA
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
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HYPOTHYROIDISM
ENDOCRINE DISORDERS
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DEHYDRATION
METABOLISM AND NUTRITION DISORDERS
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ANAEMIA
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URINARY TRACT INFECTION
INFECTIONS AND INFESTATIONS
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INVESTIGATIONS
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BACK PAIN
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DIZZINESS
NERVOUS SYSTEM DISORDERS
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NERVOUS SYSTEM DISORDERS
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DYSPNOEA
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HYPOTENSION
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PYREXIA
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UPPER RESPIRATORY TRACT INFECTION
INFECTIONS AND INFESTATIONS
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BLOOD ALKALINE PHOSPHATASE INCREASED
INVESTIGATIONS
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HYPOKALAEMIA
METABOLISM AND NUTRITION DISORDERS
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PROTEINURIA
RENAL AND URINARY DISORDERS
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PRURITUS
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
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CHILLS
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
This is a study in adults with various types of advanced cancer. The purpose of the study is to test a medicine called BI 754091 in combination with several other cancer medicines. BI 754091 is an immunotherapy. This means it may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors.
How long the participants are in the study depends on whether they benefit from treatment and whether they experience unacceptable side effects. The participants are put into different groups. Each group receives BI 754091 in combination with another medicine.
The doctors check whether the tumors shrink or disappear. The doctors also check the general health of the participants.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07395258 — A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Differe
· Phase 1
· recruiting
NCT06370871 — Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Ti
· Phase 3
· withdrawn
NCT06091930 — A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Can
· Phase 1
· active not recruiting
NCT05879978 — A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by Peop
· Phase 1
· active not recruiting
NCT05846516 — A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer
· Phase 1
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 27 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03697304.