Actively Recruiting
A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
Led by Boehringer Ingelheim · Updated on 2026-05-13
187
Participants Needed
13
Research Sites
200 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 18 years of age or older and able to give legal consent
- For endometrial and ovarian cancer patients, signed consent for target testing
- Signed consent for study participation according to international and local regulations
- Confirmed target-positivity in tumor tissue for endometrial and ovarian cancer before screening
- Diagnosis confirmed by tissue or cell analysis of germ cell tumor, endometrial cancer, or ovarian cancer
- Advanced, relapsed, or refractory disease status for germ cell tumor, endometrial cancer, or ovarian cancer
- Disease progression despite standard treatment, intolerant to or not a candidate for such treatments
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Additional inclusion criteria apply
You will not qualify if you...
- Major surgery within 28 days before the first dose of BI 3820768
- Other cancers within the past 3 years except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ, or other cured malignancies
- Known leptomeningeal disease or spinal cord compression due to disease
- Infection requiring systemic antimicrobial treatment within 7 days before first dose or clinical signs of infection within 48 hours before first dose
- Active hepatitis C virus infection or currently receiving treatment for it
- Active hepatitis B virus infection at screening
- Past or resolved hepatitis B infection allowed with testing before study start
- Additional exclusion criteria apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
Indiana University
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
3
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Not Yet Recruiting
4
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Not Yet Recruiting
5
UZ Leuven
Leuven, Belgium, 3000
Suspended
6
INS Paoli-Calmettes
Marseille, France, 13009
Not Yet Recruiting
7
Institut Gustave Roussy
Villejuif, France, 94800
Not Yet Recruiting
8
Klinikum der Universität München AÖR
München, Germany, 81377
Not Yet Recruiting
9
Universitätsklinikum Würzburg AÖR
Würzburg, Germany, 97078
Not Yet Recruiting
10
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Not Yet Recruiting
11
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan, 135-8550
Not Yet Recruiting
12
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
13
Clínica Universidad de Navarra - Madrid
Madrid, Spain, 28027
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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