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Study identifier: NCT05155332 Synced from ClinicalTrials.gov · August 05, 2026
● Suspended

A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)

Condition: Solid Tumors  ·  Sponsor: Boehringer Ingelheim

PhasePhase 1
Planned participants190
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time. This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Participants visit the site study site regularly. The number of study visits vary based on the study phase 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 t…

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (27)

Banner MD Anderson Cancer Center-Gilbert-55251Gilbert, Arizona, United States
University of ArizonaTucson, Arizona, United States
University of California San DiegoLa Jolla, California, United States
Providence St. John's Health CenterSanta Monica, California, United States
University of Colorado DenverAurora, Colorado, United States
Orlando Health Cancer InstituteOrlando, Florida, United States
M Health Fairview University of Minnesota Medical CenterMinneapolis, Minnesota, United States
Morristown Medical CenterMorristown, New Jersey, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina, United States
The University of Texas MD Anderson Cancer CenterHouston, Texas, United States
Peninsula Haematology & OncologyFrankston, Victoria, Australia
Medical University of InnsbruckInnsbruck, Austria

+ 15 more locations — full list on the registry record.

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