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New drug hopes to shrink tumors in patients out of options

NCT ID NCT07306559

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 9 times

Summary

This study tests a new drug called BI 3820768 in adults with advanced germ cell tumors, endometrial cancer, or ovarian cancer who have run out of treatment options. The drug aims to help the immune system fight cancer. Researchers will give increasing doses to find a safe amount that may shrink tumors. Participants receive weekly injections for 6 weeks, then every 3 weeks, and are followed for up to 3 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 3820768
What this could lead to
If this works, it could point toward a new treatment option for people with advanced cancers that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not work or may cause serious side effects. It is the first time this drug is tested in humans, so success is uncertain.

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 187 people

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

Started

Feb 2026

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. Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the informed consent forms (ICFs). 2. For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated written ICF1 for target testing. 3. Signed and dated ICF2 for all patients describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses. 4. Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on central laboratory testing of tumour tissue sample. 5. Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour (GCT), EC, or OVC. 6. Patients with advanced, relapsed/refractory (r/r) GCT, EC, or OVC. 7. Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, who have exhausted all established treatment options. 8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Further inclusion criteria apply. Exclusion criteria: 1. Patient with a history of a major surgery within 28 days prior to the first dose of BI 3820768 (major according to the Investigator's and/or Sponsor's assessment). 2. Previous or concomitant malignancies other than the one treated in this trial within the past 3 years except: 1. Effectively treated non-melanoma skin cancers 2. Effectively treated carcinoma in situ of the cervix 3. Effectively treated ductal carcinoma in situ 4. Other effectively treated malignancy that is considered cured by local treatment 3. Patient with known leptomeningeal disease or spinal cord compression due to disease. 4. Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to the first dose of trial medication. Patients who have any clinical signs of infection (e.g. fever or leukocytosis) within 48 h prior to the first dose of trial medication are not eligible. 5. Patients with Hepatitis-C-Virus (HCV) infection, defined as: 1. Currently receiving curative antiviral treatment for HCV infection, and/or 2. HCV viral load is above the limit of quantification (HCV RNA positive). 6. Patients with active hepatitis B virus (HBV) infection (chronic or acute); defined as having a positive hepatitis B surface antigen (HBsAg), and HBsAg test at screening. 7. Patient with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBcAb) and absence of HbsAg) are eligible. HBV DNA must be obtained in these patients prior study start. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm germ cell tumor malignant testicular germ cell tumor ovarian cancer ovarian carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced relapsed or refractory endometrial cancer Advanced relapsed or refractory germ cell tumours Advanced relapsed or refractory ovarian cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites in 6 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

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Clínica Universidad de Navarra - Madrid

    RECRUITING

    Madrid, 28027, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • INS Paoli-Calmettes

    RECRUITING

    Marseille, 13009, France

  • Indiana University

    NOT_YET_RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Japanese Foundation for Cancer Research

    RECRUITING

    Tokyo, Koto-ku, 135-8550, Japan

  • Klinikum der Universität München AÖR

    RECRUITING

    München, 81377, Germany

  • National Cancer Center Hospital East

    RECRUITING

    Chiba, Kashiwa, 277-8577, Japan

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UZ Leuven

    SUSPENDED

    Leuven, 3000, Belgium

  • Universitätsklinikum Würzburg AÖR

    RECRUITING

    Würzburg, 97078, Germany

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

More trials for these conditions

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