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

Phase I Open-label, Dose Escalation and Expansion Trial of BI 1831169 in Combination With an Anti-PD1 mAb in Japanese Patients With Advanced/Metastatic Solid Tumours

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	BI 1831169	BI 1831169
DRUG	nivolumab	nivolumab

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-01-15
• Completion: 2029-05-30
• First posted: 2025-09-16
• Last updated: 2026-03-31

Locations

1 site across 1 country: Japan