RecruitingPhase IEN originalOvarian cancerOther cancers

A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

This study is open to adults with advanced germ cell tumours, endometrial cancer, or ovarian cancer whose previous treatments were not successful. People can join the study if they have no remaining treatment options or if standard therapy is not suitable. The purpose of this study is to test increasing doses of BI 3820768 to find a dose that people with these types of cancer can tolerate and that may make tumours shrink. BI 3820768 is a type of treatment that may help the immune system fight cancer. This is the first time BI 3820768 is being tested in humans. The study has 2 parts based on the way BI 3820768 is given. Depending on when participants join the study, they will receive BI 3820768 through one of two ways to inject the study medicine. All participants receive the study medicine. The medicine is given as an injection once a week for 2 cycles of 3 weeks each, followed by doses every 3 weeks. Participants are in the study for up to 3 years if they are benefiting from the treatment. During this time, they visit the study site regularly, and some visits will require overnight stays. Doctors will regularly check the size of the tumour and whether it has spread. Researchers want to find the highest dose of BI 3820768 that participants can tolerate by looking at the number of participants with certain severe health problems. The doctors also regularly check participants' health, take blood samples, and note any unwanted effects.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Pacjent musi mieć ukończone 18 lat.
  • Pacjent musi wyrazić pisemną zgodę na udział w badaniu.
  • Badanie potwierdza obecność specyficznych cech w próbce guza (dla raka endometrium i jajnika).
  • Pacjent musi mieć potwierdzony nowotwór zarodkowy, raka endometrium lub raka jajnika.
  • Choroba pacjenta jest w zaawansowanym stadium lub nawracająca/opororna na leczenie.
  • Pacjent nie reagował na tradycyjne leczenie, nie toleruje go lub nie ma innych opcji leczenia.
  • Ogólny stan zdrowia pacjenta pozwala na udział w badaniu (dobry stan ogólny).

✗ Disqualifies

  • Pacjent przeszedł dużą operację w ciągu ostatnich 28 dni.
  • Pacjent miał inne nowotwory w ciągu ostatnich 3 lat (z pewnymi wyjątkami, np. leczony rak skóry).
  • Pacjent ma przerzuty do opon mózgowo-rdzeniowych lub ucisk na rdzeń kręgowy.
  • Pacjent wymaga leczenia infekcji w ciągu 7 dni przed podaniem pierwszego leku w badaniu.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 22, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (13)

Valkyrie Clinical Trials

Los Angeles, United States

Indiana University

Indianapolis, United States

The University of Texas MD Anderson Cancer Center

Houston, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

INS Paoli-Calmettes

Marseille, France

Institut Gustave Roussy

Villejuif, France

Klinikum der Universität München AÖR

München, Germany

Universitätsklinikum Würzburg AÖR

Würzburg, Germany

National Cancer Center Hospital East

Chiba, Kashiwa, Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, Japan

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Clínica Universidad de Navarra - Madrid

Madrid, Spain

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/8/2026.

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