BI 754091

DRUG9 trials

Sponsors

Boehringer Ingelheim, OSE Immunotherapeutics, Amal Therapeutics

Conditions

Anal Canal Squamous Cell CarcinomaCarcinoma, Non-Small-Cell LungColorectal CancerHead and Neck NeoplasmsLiver Metastasis Colon CancerMSSMetastatic Colorectal CancerNeoplasm Metastasis

Phase 1

A Trial to Find and Investigate a Safe Dose of a New Substance (BI 754091) for Patients With Solid Tumours

CompletedNCT02952248

Boehringer IngelheimNeoplasms

Start: 2016-11-21End: 2023-08-01Updated: 2026-01-27

A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread

TerminatedNCT03166631

Boehringer IngelheimCarcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Neoplasms

Start: 2017-09-08End: 2020-10-28Updated: 2024-11-19

This Study Tests How BI 754111 is Distributed in Patients With Advanced Non-small Cell Lung Cancer or Patients With Head and Neck Cancer Who Are Treated With BI 754091

TerminatedNCT03780725

Boehringer IngelheimCarcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms

Start: 2019-01-22End: 2020-12-08Updated: 2026-01-13

A Study to Find the Best Dose of BI 836880 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer

CompletedNCT03972150

Boehringer IngelheimNeoplasms

Start: 2019-06-12End: 2022-03-28Updated: 2025-10-06

A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours

CompletedNCT03990233

OSE ImmunotherapeuticsSolid Tumor, Adult

Start: 2019-04-16End: 2025-04-30Updated: 2025-06-26

Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer

Active, not recruitingNCT04046445

Amal TherapeuticsColorectal Cancer, Liver Metastasis Colon Cancer, Metastatic Colorectal Cancer +3

Start: 2019-07-22End: 2025-08-31Target: 96Updated: 2025-01-29

A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)

CompletedNCT04147234

Boehringer IngelheimNeoplasms

Start: 2020-08-03End: 2024-03-21Updated: 2025-08-19

A Study to Test Different Doses of BI 765063 Alone and in Combination With BI 754091 in Japanese Patients With Different Types of Advanced Cancer (Solid Tumors)

CompletedNCT04653142

Boehringer IngelheimSolid Tumors

Start: 2020-12-15End: 2022-04-20Updated: 2022-05-10

Phase 2

A Study to Test BI 754091 Alone or in Combination With BI 836880 in People Who Have Advanced Anal Cancer

WithdrawnNCT04499352

Boehringer IngelheimAnal Canal Squamous Cell Carcinoma

Start: 2020-09-14End: 2020-10-19Updated: 2021-11-15

Related Papers

The Second Mitochondria-Derived Activator of Caspases Mimetic BI 891065 in Patients With Advanced Solid Tumors: Results From Two Phase I Studies.

2025-12-011 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

Synergistic effects of Smac mimetic APG-1387 with anti-PD-1 antibody are attributed to increased CD3 + NK1.1 + cell recruitment secondary to induction of cytokines from tumor cells

Cancer Cell International2024-05-243 citations

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

Cancer Immunology Immunotherapy2024-03-303 citations

Immunoinformatics Approach to Design a Chimeric CD70‐Peptide Vaccine against Renal Cell Carcinoma

Journal of Immunology Research2024-01-013 citations

Phase I study of the VEGF/Ang-2 inhibitor BI 836880 alone or combined with the anti-programmed cell death protein-1 antibody ezabenlimab in Japanese patients with advanced solid tumors.

2023-05-045 citations

<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

Abstract CT570: KISIMA-01: A first-in-human trial of the heterologous prime-boost vaccine ATP128/VSV-GP128 with ezabenlimab (BI 754091) in patients with stage IV colorectal cancer

Cancer Research2022-06-152 citations

Abstract CT507: ATP128 vaccine with ezabenlimab promotes antigen-specific immune responses in stage IV colorectal cancer in the KISIMA-01 phase 1b trial

Cancer Research2022-06-151 citations

Abstract CT217: Phase I, first-in-human trial evaluating BI 1387446 (STING agonist) alone and in combination with ezabenlimab (BI 754091; anti-PD-1) in solid tumors

Cancer Research2021-07-0110 citations

Abstract 1951: SMAC mimetic and BET inhibitor - a promising combination for solid cancer treatment

Cancer Research2021-07-011 citations

Safety, pharmacokinetics, efficacy, and preliminary biomarker data of first-in-class BI 765063, a selective SIRPα inhibitor: Results of monotherapy dose escalation in phase 1 study in patients with advanced solid tumors.

Journal of Clinical Oncology2021-05-2024 citations

408 Phase I, first-in-human trial evaluating BI 1387446 (stimulator of interferon genes [STING] agonist) alone and combined with BI 754091 (anti-programmed cell death [PD]-1) in solid tumors

Regular and Young Investigator Award Abstracts2020-11-016 citations

Safety of BI 754111, an anti-LAG-3 monoclonal antibody (mAb), in combination with BI 754091, an anti-PD-1 mAb, in patients with advanced solid tumors.

Journal of Clinical Oncology2020-05-2013 citations

Abstract 4558: In vitro and in vivo characterization of the PD-1 targeting antibody BI 754091

Cancer Research2018-07-011 citations

Phase I trial of the programmed death receptor 1 (PD-1) inhibitor, BI 754091, in patients (pts) with advanced solid tumors.

Journal of Clinical Oncology2018-02-103 citations