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A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
Sponsor: Boehringer Ingelheim
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.
Official title: A Phase I Study to Determine the Safety and Tolerability of BI 3820768 in Patients With Advanced Relapsed or Refractory Germ Cell Tumours, Endometrial Cancer, or Ovarian Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
187
Start Date
2026-02-27
Completion Date
2029-12-31
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
BI 3820768
BI 3820768
Locations (13)
Valkyrie Clinical Trials
Los Angeles, California, United States
Indiana University
Indianapolis, Indiana, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 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