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RECRUITING Phase 1

A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)

NCT07306559 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 187 participants
Start Date 2026-02-27
Est. Completion 2029-12-31
Phase Phase 1

Sponsor

Boehringer Ingelheim

203 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07306559 reports 13 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07306559?

The interventions under investigation include: BI 3820768 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07306559?

This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial