drugset / Trial / NCT05068102

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

NCT05068102

Phase 1 Active not recruiting 14 enrolled Boehringer Ingelheim
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2022-03-03
Primary completion
2026-09-16
Completion
2026-09-16

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 765063 Monoclonal antibody Intravenous
Subject BI 770371 Unknown Intravenous
Subject [89Zr]Zr- BI 765063 Unknown
Subject [89Zr]Zr- BI 770371 Unknown
Background Ezabenlimab Monoclonal antibody Intravenous