A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
Start Date
2/27/2026
Completion Date
12/31/2029
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BI 3820768
Conditions
Locations
Valkyrie Clinical Trials
Los Angeles, California 90067
United States
Indiana University
Indianapolis, Indiana 46202
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Cliniques Universitaires Saint-Luc
Brussels, 1200
Belgium
UZ Leuven
Leuven, 3000
Belgium
INS Paoli-Calmettes
Marseille, 13009
France
Institut Gustave Roussy
Villejuif, 94800
France
Klinikum der Universität München AÖR
München, 81377
Germany
Universitätsklinikum Würzburg AÖR
Würzburg, 97078
Germany
National Cancer Center Hospital East
Chiba, Kashiwa, 277-8577
Japan
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550
Japan
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Clínica Universidad de Navarra - Madrid
Madrid, 28027
Spain