Clinical Trial

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 Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
This study is open to adults with advanced head and neck cancer, skin cancer, or non-small cell lung cancer. People can take part if previous treatments were not successful. The purpose of this study is to find out how 2 medicines called BI 765063 and BI 770371 are taken up in the tumours and how they get distributed in the body. In addition to BI 765063 or BI 770371, participants also receive ezabenlimab. BI 765063, BI 770371 and ezabenlimab are antibodies that may help the immune system fight cancer. Such therapies are also called immune checkpoint inhibitors. Participants get either BI 765063 or BI 770371 in combination with ezabenlimab as an infusion into a vein every 3 weeks. In the first weeks, doctors check how BI 765063 and BI 770371 are taken up in tumours. To do so, the doctors use imaging methods (PET/CT scans). For this, participants get BI 765063 or BI 770371 injected in a labelled form up to 2 times. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors regularly check participants' health and take note of any unwanted effects.
Protocol Amendment History 5 changes
notable Primary completion moved earlier: 2026-09-16 -> 2026-01-22 2026-08-05
minor Completion pushed: 2026-09-16 -> 2027-07-14 2026-08-05
notable Primary completion pushed: 2026-05-29 -> 2026-09-16 2026-05-28
notable Primary completion pushed: 2026-04-03 -> 2026-05-29 2026-04-21
minor Completion pushed: 2026-05-31 -> 2026-08-06 2026-04-21
Trial Details
NCT Number NCT05068102
Lead Sponsor Boehringer Ingelheim
Conditions Carcinoma, Squamous Cell of Head and Neck (HNSCC), Melanoma, Non-small Cell Lung Cancer (NSCLC)
Enrollment 14 participants
Start Date 2022-03-03
Primary Completion 2026-01-22 (estimated)
Study Completion 2027-07-14 (estimated)
Updated on ClinicalTrials.gov 2026-08-04