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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
187
BI 3820768
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
INS Gustave Roussy
Villejuif, France
Klinikum der Universität München AÖR
München, Germany
Universitätsklinikum Würzburg AÖR
Würzburg, Germany
National Cancer Center Hospital East
Chiba, Kashiwa, Japan
...and 3 more locations
Occurrence of treatment-emergent AEs
AEs=Adverse Events
Time frame: up to 3 years.
Occurrence of DLT(s)
DLT(s)=Dose Limiting Toxicities
Time frame: up to 3 years.
Objective response (OR)
Defined as the best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where Best overall response (BOR) is determined according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.
Time frame: up to 3 years.
Maximum measured plasma concentration of BI 3820768 after the first administration
Time frame: up to 24 hours.
Maximum measured plasma concentration of BI 3820768 after multiple administrations
Time frame: up to 3 years.
Area under the concentration-time curve of BI 3820768 after the first administration
Time frame: up to 24 hours.
Area under the concentration-time curve of BI 3820768 after multiple administrations
Time frame: up to 3 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.