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Can a new drug rally the immune system against Hard-to-Treat cancers?

NCT ID NCT07744152

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 137 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Clínica Universidad de Navarra

    Navarra, 31008, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Klinikum der Universität München AÖR

    München, 81377, Germany

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC AVL)

    Amsterdam, 1066CX, Netherlands

  • Shanghai East Hospital

    Shanghai, 200123, China

  • Technische Universität Dresden

    Dresden, 01307, Germany

  • UZ Leuven

    Leuven, 3000, Belgium

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