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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 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. The trial reports 13 study locations across 4 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07306559
The ClinicalTrials.gov registry entry for NCT07306559 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 187 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
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 reports 13 study locations spanning 4 distinct geographic areas - top geographies include 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.
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