drugset / Trial / NCT07176975

A Study to Test How Well Different Doses of BI 1831169 in Combination With an Anti-PD1 Antibody Are Tolerated in Japanese People With Different Advanced Cancers

NCT07176975

Phase 1 Suspended 46 enrolled Boehringer Ingelheim
Non-randomizedSequentialOpen-labelTreatment

Summary

This study is open to Japanese adults with different types of advanced cancer (solid tumors). People can join the study if their cancer has spread, and previous treatments were not successful or no treatments exist. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people can tolerate when taken together with an anti-PD1 antibody. The anti-PD1 antibody is already used to treat different cancers. Participants receive BI 1831169 together with an anti-PD1 antibody, which is given as an infusion into a vein for up to 1 year. Participants visit the study site regularly. The number of site visits vary based on the study part and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.

Timeline

Start
2027-08-03
Primary completion
2028-12-19
Completion
2029-05-22

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 1831169 Other / unclassified
Background Nivolumab Monoclonal antibody Intravenous

Indications