Can a new drug rally the immune system against Hard-to-Treat cancers?
NCT ID NCT07744152
First seen Aug 04, 2026 · Last updated Sep 02, 2026 · Updated 5 times
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 137 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria : 1. Patients must have histologically confirmed unresectable advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), triple negative breast cancer (TNBC), esophageal squamous cell cancer (ESCC), bladder cancer (BC), vulvar cancer (VC) and cervical cancer (CC) and have no remaining standard treatment options (including those who have failed or are intolerant to standard therapy). 2. Patients ≥18 years of age and over the legal age of consent as required by local legislation at the time of signature of the informed consent form (ICF). 3. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Patient must have at least one measurable lesion outside of the central nervous system (CNS) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumour lesions that have been irradiated ≥28 days before the start of treatment, and have subsequently had documented progression, may be chosen as measurable lesions only in the absence of measurable lesions that have not been irradiated. 5. Further inclusion criteria apply. Exclusion criteria : 1. Prior treatment with systemic anticancer drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of study intervention. 2. Treatment with extensive field radiotherapy including whole brain irradiation within 14 days prior to first administration. 3. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV). 4. History or presence of cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of III or IV, corrected QT (QTc) prolongation \> 480 msec, unstable angina or poorly controlled arrhythmia which are considered as clinically relevant by the Investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to treatment. 5. Further exclusion criteria apply.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 5 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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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Shanghai East Hospital
Shanghai, 200123, China
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Technische Universität Dresden
Dresden, 01307, Germany
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UZ Leuven
Leuven, 3000, Belgium
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