A Study to Test Different Doses of BI 1831169 Alone and in Combination With Ezabenlimab in People With Different Types of Advanced Cancer (Solid Tumors).

• Status: Not yet recruiting
• Trial end date: 2025-07-03

Summary

This study is open to adults with different types of advanced cancer (solid tumours) that are accessible for injection. People for whom previous treatment was not successful or for whom no other treatment options exist can join the study.

The study tests a medicine called BI 1831169 alone and in combination with another medicine called ezabenlimab. BI 1831169 and ezabenlimab may help the immune system fight cancer. In this study, BI 1831169 is given to people for the first time.

The study has 2 parts. The purpose of the first part is to find the highest dose of BI 1831169 the participants can tolerate. Part 1 also tests whether BI 1831169 can make the tumours shrink. The purpose of the second part is to find the highest dose of BI 1831169 in combination with ezabenlimab that the participants can tolerate.

Participants get BI 1831169 as an injection into the tumour, or as an infusion into the vein, or both (injection and infusion). Ezabenlimab is given as an infusion into a vein. Participants get the medicines about every 3 weeks.

Participants who get BI 1831169 alone receive this treatment for up to 3 months. Participants who take the combination treatment, get BI 1831169 for up to 3 months and ezabenlimab for up to a year. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1831169 or ezabenlimab.

• Phase: Phase 1

Details

• Lead Sponsor: Boehringer Ingelheim