Can a new drug rally the immune system against Hard-to-Treat cancers?
NCT ID NCT07744152
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental medicine called BI 3822971 in adults with advanced or metastatic solid cancers, such as lung, head and neck, breast, esophageal, bladder, vulvar, or cervical cancer, who have no standard treatment options left. The goal is to find out how safe and tolerable the drug is, and to identify a dose and schedule for future studies. BI 3822971 is designed to help the immune system fight cancer, and all participants receive the drug—there is no placebo. Doctors will monitor participants for side effects and check tumor size regularly, with participation lasting up to 3 years if the treatment is working.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- BI 3822971, an experimental drug designed to help the immune system fight cancer
- What this could lead to
- If this drug proves safe and tolerable, it could become a new treatment option for people with advanced solid cancers who have run out of standard therapies.
- What could go wrong
- This is a first-in-human, early-phase trial, so the drug may not work as hoped or may cause unexpected side effects. The results will only show safety and dosing, not whether it actually shrinks tumors.
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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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Clínica Universidad de Navarra
Navarra, 31008, Spain
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Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
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Hospital Universitari Vall d'Hebron
Barcelona, 08035, Spain
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Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
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Hospital del Mar
Barcelona, 08003, Spain
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Klinikum der Universität München AÖR
München, 81377, Germany
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Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)
Amsterdam, 1066CX, Netherlands
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Technische Universität Dresden
Dresden, 01307, Germany
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UZ Leuven
Leuven, 3000, Belgium
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Other studies related to the condition(s) this trial covers.
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- Can a new infusion drug shrink Hard-to-Treat tumors?