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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 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-31

No results posted yet for this study

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

Interventions

DRUG

BI 1831169

BI 1831169

DRUG

nivolumab

nivolumab

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-01-15
Completion
2029-05-30

Countries

  • Japan

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07176975 on ClinicalTrials.gov