Ezabenlimab

DRUG20 trials

Sponsors

Institut Bergonie, Institut Bergonie, Centre Hospitalier Regional Universitaire, Boehringer Ingelheim, Johann Wolfgang Goethe University Hospital

Conditions

Adult patients with locally advanced/metastatic solid tumorsAdvanced Soft Tissue SarcomaAdvanced TumorsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous Cell of Head and Neck (HNSCC)Colorectal CancerColorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Carcinoma, Hepatocellular, Head and Neck Neoplasms, Gastrointestinal NeoplasmsGastrointestinal Cancer

Early Phase 1

This Study Aims to Find a Safe and Effective Dose of BI 754091. The Study Also Aims to Find Safe and Effective Doses of BI 754091 and BI 754111 in Combination. This Study is Done in Asian Patients With Different Types of Cancer

CompletedNCT03433898

Boehringer IngelheimNeoplasms

Start: 2018-02-23End: 2023-07-20Updated: 2025-12-19

Phase 1

This Study Tests the New Medicine BI 754111 Alone or in Combination With Another New Substance BI 754091 in Patients With Advanced Cancer. The Study Tests Different Doses to Find the Best Dose for Continuous Treatment.

CompletedNCT03156114

Boehringer IngelheimCarcinoma, Non-Small-Cell Lung, Neoplasms

Start: 2017-06-13End: 2023-06-06Updated: 2026-01-26

Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Ezabenlimab in Patients With Recurrent HER2-positive Glioblastoma

Active, not recruitingNCT03383978

Johann Wolfgang Goethe University HospitalGlioblastoma

Start: 2017-12-01End: 2026-06-30Target: 42Updated: 2024-03-27

A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours

CompletedNCT03468426

Boehringer IngelheimNeoplasms, Non-squamous, Non-Small-Cell Lung Cancer

Start: 2018-07-05End: 2024-09-12Updated: 2025-11-07

A Study in Patients With Different Types of Advanced Cancer (Solid Tumors) to Test Different Doses of BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab) and BI 754111 or BI 907828 (Brigimadlin) in Combination With BI 754091 (Ezabenlimab)

CompletedNCT03964233

Boehringer IngelheimNeoplasms

Start: 2019-06-20End: 2026-02-06Updated: 2026-02-18

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface

CompletedNCT04752215

Boehringer IngelheimColorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Carcinoma, Hepatocellular, Head and Neck Neoplasms, Gastrointestinal Neoplasms

Start: 2021-05-18End: 2024-12-17Updated: 2026-02-02

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer

Active, not recruitingNCT04958239

Boehringer IngelheimNeoplasms

Start: 2021-10-18End: 2028-02-17Updated: 2026-03-17

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab

Active, not recruitingNCT05068102

Boehringer IngelheimCarcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)

Start: 2022-03-03End: 2026-05-31Updated: 2026-02-18

A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

Active, not recruitingNCT05249426

Boehringer IngelheimHead and Neck Squamous Cell Carcinoma (HNSCC)

Start: 2022-04-12End: 2026-07-31Updated: 2026-01-21

A Study in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated

Active, not recruitingNCT05327946

Boehringer IngelheimSolid Tumors

Start: 2022-05-17End: 2026-09-30Updated: 2025-10-28

A Study in People With Colorectal Cancer to Test Whether Ezabenlimab or Pembrolizumab in Combination With BI 765063 Lead to Side Effects or Delays in Surgery

TerminatedNCT05446129

Boehringer IngelheimColorectal Cancer

Start: 2022-09-27End: 2023-11-08Updated: 2025-03-13

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

RecruitingNCT05471856

Boehringer IngelheimSolid Tumors

Start: 2023-02-24End: 2028-09-13Target: 66Updated: 2025-12-17

A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer

Active, not recruitingNCT05846516

Boehringer IngelheimPancreatic Ductal Adenocarcinoma

Start: 2023-05-11End: 2027-06-27Updated: 2026-04-01

A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3

Active, not recruitingNCT05879978

Boehringer IngelheimNeuroendocrine Neoplasms, Small Cell Lung Carcinoma (SCLC)

Start: 2023-06-27End: 2026-06-30Updated: 2026-04-02

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6

RecruitingNCT06091930

Boehringer IngelheimColorectal Cancer, Gastrointestinal Cancer, Head and Neck Cancer +3

Start: 2024-02-16End: 2028-09-10Target: 97Updated: 2026-03-04

A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)

Not yet recruitingNCT07395258

Boehringer IngelheimSolid Tumors

Start: 2026-03-30End: 2032-02-12Target: 60Updated: 2026-03-27

Phase 2

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

CompletedNCT03697304

Boehringer IngelheimAdvanced Tumors, Metastatic Solid Tumors, Neoplasm Metastasis

Start: 2019-03-19End: 2024-12-03Updated: 2026-01-27

EMPIRE : Targeting MDM2 and PD1 in tumors with tertiary lymphoid structures

CompletedCTIS2023-506823-28-00

Institut Bergonie, Institut BergonieAdult patients with locally advanced/metastatic solid tumors

Start: 2024-06-14End: 2024-07-01Target: 120Updated: 2024-06-14

INTERACT-ION : Ezabenlimab (BI 754091) and mDCF (docetaxel, cisplatin and 5-fluorouracil) followed by chemoradiotherapy in patients with stage III squamous cell anal carcinoma. A phase II study.

Not yet recruitingCTIS2024-514083-31-00

Centre Hospitalier Regional Universitairesquamous cell anal carcinoma

Target: 55Updated: 2024-07-26

Phase 3

Brightline-3: A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma

WithdrawnNCT06370871

Boehringer IngelheimAdvanced Soft Tissue Sarcoma, Myxofibrosarcoma (MFS), Undifferentiated Pleomorphic Sarcoma (UPS)

Start: 2024-06-27End: 2028-10-13Updated: 2024-07-17

Related Papers

Abstract LB-A002: Open-label, Phase Ib dose-expansion study assessing the efficacy of the CD137/FAP agonist BI 765179 plus pembrolizumab as first-line therapy in metastatic or incurable, recurrent PD-L1-positive head and neck squamous cell carcinoma

Cancer Immunology Research2026-03-05

A phase 1b study to evaluate the safety, tolerability and preliminary efficacy of a heterologous prime boost vaccination (ATP150/ATP152/ATP162, VSV-GP154) and ezabenlimab (BI 754091) in patients with pancreatic ductal adenocarcinoma.

Journal of Clinical Oncology2026-01-10

P18.15.A IMMUNOCOMPETENT GLIOBLASTOMA ORGANOIDS FOR PERSONALIZED IMMUNE PROFILING

Neuro-Oncology2025-10-01

An open-label, phase Ib dose-expansion study to assess the efficacy of CD137/FAP agonist BI 765179 plus pembrolizumab as a first-line treatment in metastatic or incurable, recurrent programmed cell death ligand-1 (PD-L1)-positive head and neck squamous cell carcinoma (HNSCC).

Journal of Clinical Oncology2025-05-281 citations

An open-label, phase Ib trial of the SIRPα inhibitor BI 765063 in combination with the PD-1 inhibitor ezabenlimab and cetuximab in patients (pts) with head and neck squamous cell carcinoma.

Journal of Clinical Oncology2025-05-28

An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors.

Journal of Clinical Oncology2025-05-28

Abstract CT110: An open-label, phase Ib dose-expansion study to assess the efficacy of CD137/FAP agonist BI 765179 plus pembrolizumab as a first-line treatment in metastatic or incurable, recurrent programmed cell death ligand-1 (PD-L1)-positive, head and neck squamous cell carcinoma (HNSCC)

Cancer Research2025-04-25

Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors

Future Oncology2025-01-144 citations

Phase Ib Study of BI 836880 (VEGF/Ang2 nanobody) in Combination With Ezabenlimab (anti–PD-1 antibody) in Patients With Advanced or Metastatic Solid Tumors

JCO oncology advances.2025-01-012 citations

Comprehensive biomarker and modeling approach to support dose finding for BI 836880, a VEGF/Ang-2 inhibitor

Journal of Translational Medicine2024-10-142 citations

A phase Ia/Ib, non-randomized, open-label, dose escalation and expansion trial of the B7-H6/CD3 T-cell engager BI 765049 with or without ezabenlimab in Asian patients with advanced solid tumors.

Journal of Clinical Oncology2024-06-01

Ezabenlimab (BI 754091), an anti-PD-1 antibody, in patients with advanced solid tumours

Cancer Immunology Immunotherapy2024-03-303 citations

Efficacy and safety of brigimadlin (BI 907828), an MDM2–p53 antagonist, in patients (pts) with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.

Journal of Clinical Oncology2024-01-208 citations

650 Neoadjuvant ezabenlimab or pembrolizumab in combination with an anti-SIRPα antibody in resectable colorectal cancer

Regular and Young Investigator Award Abstracts2023-10-31

P06.06.B PD-1 CHECKPOINT INHIBITION IN CONJUNCTION WITH NK-92/5.28.Z CELLS IS EFFECTIVE IN AN ADVANCED-STAGE GLIOBLASTOMA MOUSE MODEL AND INDUCES A CD4-ENRICHED T CELL RESPONSE

Neuro-Oncology2023-09-01

<sup>89</sup>Zr-immuno-PET using the anti-LAG-3 tracer [<sup>89</sup>Zr]Zr-BI 754111: demonstrating target specific binding in NSCLC and HNSCC.

2023-03-0224 citations

Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials.

Journal of Clinical Oncology2023-01-249 citations

Two phase I studies of BI 836880, a vascular endothelial growth factor/angiopoietin-2 inhibitor, administered once every 3 weeks or once weekly in patients with advanced solid tumors

ESMO Open2022-09-1213 citations

Combination of two novel blocking antibodies, anti-PD-1 antibody ezabenlimab (BI 754091) and anti-LAG-3 antibody BI 754111, leads to increased immune cell responses

OncoImmunology2022-06-1621 citations

A phase Ia/Ib, dose-escalation/expansion study of BI 907828 in combination with BI 754091 (ezabenlimab) and BI 754111 in patients (pts) with advanced solid tumors.

Journal of Clinical Oncology2022-06-017 citations

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