A Phase 1 interventional study of BI 3820768 in Advanced Relapsed or Refractory Germ Cell Tumours, Advanced Relapsed or Refractory Endometrial Cancer and Advanced Relapsed or Refractory Ovarian Cancer, sponsored by Boehringer Ingelheim. Recruiting at 13 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
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.
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's planned enrollment of 187 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Further inclusion criteria apply.
Exclusion criteria:
Previous or concomitant malignancies other than the one treated in this trial within the past 3 years except:
Patients with Hepatitis-C-Virus (HCV) infection, defined as:
Further exclusion criteria apply.
Drug: BI 3820768
Drug: BI 3820768
BI 3820768
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.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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