BI 3820768
DrugBI 3820768
NCT Number: NCT07306559
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Cliniques Universitaires Saint-Luc, Brussels, Belgium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Further inclusion criteria apply.
Exclusion criteria
Further exclusion criteria apply.
BI 3820768
Time frame: up to 3 years.
AEs=Adverse Events
Time frame: up to 3 years.
DLT(s)=Dose Limiting Toxicities
Time frame: up to 3 years.
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 24 hours.
Time frame: up to 3 years.
Time frame: up to 24 hours.
Time frame: up to 3 years.
Contact information is provided by the study sponsor or research team.
Boehringer Ingelheim
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07285044
Adenocarcinoma, Adnexal Diseases
Jacksonville, Florida, United States
View Trial DetailsNCT05564377
Adnexal Diseases, Advanced Malignant Solid Neoplasm
Birmingham, Alabama, United States
View Trial DetailsNCT04657068
Acinar Cell Carcinoma, Adenocarcinoma
Birmingham, Alabama, United States
View Trial DetailsNCT05797168
Adenocarcinoma, Adenocarcinoma of Lung
Duarte, California, United States
View Trial Details