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NCT07306559 · ClinicalTrials.gov registry record · Phase 1
A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
A Phase 1 study of Advanced Relapsed or Refractory Germ Cell Tumours and Advanced Relapsed or Refractory Endometrial Cancer, sponsored by Boehringer Ingelheim.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 187
- Enrollment target
- 13
- Study locations
NCT07306559: Recruiting Phase 1 study of Advanced Relapsed or Refractory Germ Cell Tumours and Advanced Relapsed or Refractory Endometrial Cancer, sponsored by Boehringer Ingelheim.
NCT07306559 is a Phase 1 study of Advanced Relapsed or Refractory Germ Cell Tumours and Advanced Relapsed or Refractory Endometrial Cancer that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 187 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (212% higher). The trial reports 13 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07306559, a Phase 1 study of Advanced Relapsed or Refractory Germ Cell Tumours and Advanced Relapsed or Refractory Endometrial Cancer, is actively recruiting participants, sponsored by Boehringer Ingelheim.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 187 participants
- Enrollment target
- 13
- Study locations
Study 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.
Primary Outcome
AEs=Adverse Events
Conditions Studied
Interventions
- DRUG BI 3820768
Study Locations (13)
Other
- Cliniques Universitaires Saint-Luc - Brussels
- UZ Leuven - Leuven
- INS Paoli-Calmettes - Marseille
- Institut Gustave Roussy - Villejuif
- Klinikum der Universität München AÖR - München
- Universitätsklinikum Würzburg AÖR - Würzburg
- National Cancer Center Hospital East - Chiba, Kashiwa
- Japanese Foundation for Cancer Research - Tokyo, Koto-ku
- Hospital Universitari Vall D Hebron - Barcelona
- Clínica Universidad de Navarra - Madrid - Madrid
California
- Valkyrie Clinical Trials - Los Angeles
Indiana
- Indiana University - Indianapolis
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2026-02-27 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
What NCT07306559 shows while recruiting
NCT07306559 is an interventional study that assigns participants to a tested intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (212% higher).
The record links to 3 conditions, with Advanced Relapsed or Refractory Germ Cell Tumours appearing as the primary indexed condition, and to 1 intervention - of which BI 3820768 is the first listed.
NCT07306559 lists 13 locations in 4 states (Other, California, Indiana).
Frequently Asked Questions
What is clinical trial NCT07306559 about?
NCT07306559 is a clinical study titled "A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)". 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 increa...
What is the current status of trial NCT07306559?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 187 participants. The study started on 2026-02-27. Estimated completion is 2029-12-31.
What conditions does trial NCT07306559 study?
This clinical trial studies the following conditions: Advanced Relapsed or Refractory Germ Cell Tumours, Advanced Relapsed or Refractory Endometrial Cancer, Advanced Relapsed or Refractory Ovarian Cancer.
What interventions are being tested in trial NCT07306559?
The interventions under investigation include: BI 3820768 (DRUG).
Who is sponsoring clinical trial NCT07306559?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07306559 being conducted?
This trial has 13 study locations across California, Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07306559's enrollment target sits among peer trials
187 291st of 2000 higher than 1,710 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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