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

Sponsor
Boehringer Ingelheim
Study ID
NCT07176975
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI 1831169 — DRUG
    BI 1831169
  • nivolumab — DRUG
    nivolumab

Study Details

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.

Key Dates

Start date
Aug 3, 2027
Status verified
May 2026
Primary completion
Dec 19, 2028
Completion
May 22, 2029

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation part: BI 1831169 dose level 1 + anti-PD-1 antibody
  • Experimental: Dose escalation part: BI 1831169 dose level 2 + anti-PD-1 antibody
  • Experimental: Dose escalation part: BI 1831169 dose level 3 + anti-PD-1 antibody
  • Experimental: Dose escalation part: BI 1831169 dose level 4 + anti-PD-1 antibody
  • Experimental: Dose expansion part: BI 1831169 + anti-PD-1 antibody

Primary Outcome Measure

Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period [ Time Frame: up to 6 weeks ]

Central Contacts

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