New cancer drug combo targets Hard-to-Treat tumors
NCT ID NCT05155332
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 3 times
Summary
This early-phase study tests a new drug, BI 1831169, given alone or with an immunotherapy (anti-PD-1 antibody) in adults with advanced solid tumors that cannot be removed by surgery or have spread. The main goals are to find the highest safe dose and see if the treatment shrinks tumors. Participants receive the drug every 3 weeks for up to 3 months (alone) or up to 1 year (with immunotherapy). The trial is currently on hold.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- BI 1831169 (injected into tumor or infused into vein) and an anti-PD-1 antibody (checkpoint inhibitor, infused into vein)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced solid tumors that are hard to treat.
- What could go wrong
- This is a very early (Phase 1) and small study, so the treatment may not work or may cause side effects. The trial is currently suspended, which adds uncertainty.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
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Banner MD Anderson Cancer Center-Gilbert-55251
Gilbert, Arizona, 85234, United States
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CTR Eugène Marquis
Rennes, 35042, France
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Clínica Universidad de Navarra
Pamplona, 31008, Spain
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Fundación Jiménez Díaz
Madrid, 28040, Spain
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HOP Timone
Marseille, 13385, France
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Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08907, Spain
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INS Bergonie
Bordeaux, 33000, France
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Institut Gustave Roussy
Villejuif, 94805, France
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Istituto Di Candiolo
Candiolo (TO), 10060, Italy
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M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
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Medical University of Innsbruck
Innsbruck, 6020, Austria
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Morristown Medical Center
Morristown, New Jersey, 07960, United States
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Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
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Peninsula Haematology & Oncology
Frankston, Victoria, 3199, Australia
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
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Providence St. John's Health Center
Santa Monica, California, 90404, United States
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Salzburg Cancer Research Institute
Salzburg, 5020, Austria
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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UZ Leuven
Leuven, 3000, Belgium
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Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
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University Hospital Geneva
Geneva, 1205, Switzerland
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University of Arizona
Tucson, Arizona, 85719, United States
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University of California San Diego
La Jolla, California, 92037, United States
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University of Colorado Denver
Aurora, Colorado, 80045, United States
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Universitätsklinikum Tübingen
Tübingen, 72076, Germany
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Universitätsklinikum Ulm
Ulm, 89081, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can your own immune cells beat advanced cancer?
- Can a Dual-Pronged antibody outsmart advanced solid tumors?
- Can a new infusion drug shrink Hard-to-Treat tumors?
- Tumor DNA mapping may unlock personalized cancer therapies
- Can a new drug combo shrink Hard-to-Treat tumors?
- Can a protein calm the immune System's overreaction to cancer treatment?