RecruitingPhase 1NCT07306559

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

A Phase I Study to Determine the Safety and Tolerability of BI 3820768 in Patients With Advanced Relapsed or Refractory Germ Cell Tumours, Endometrial Cancer, or Ovarian Cancer


Sponsor

Boehringer Ingelheim

Enrollment

187 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests different doses of a new experimental drug called BI 3820768 in adults with advanced solid tumors (cancers), to find a safe and tolerable dose and understand how the body processes the drug. **You may be eligible if...** - You are 18 or older (or the legal age of consent in your country) - You have advanced solid tumor cancer that has progressed despite available treatments - You have adequate organ function - You are able to provide signed informed consent **You may NOT be eligible if...** - You are not part of the oncology care team (for healthcare provider participants) - You have certain health conditions or prior treatments that make participation unsafe - You do not meet the performance status or lab criteria the study requires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBI 3820768

BI 3820768


Locations(13)

Valkyrie Clinical Trials

Los Angeles, California, United States

Indiana University

Indianapolis, Indiana, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Cliniques Universitaires Saint-Luc

Brussels, Belgium

UZ Leuven

Leuven, Belgium

INS Paoli-Calmettes

Marseille, France

Institut Gustave Roussy

Villejuif, France

Klinikum der Universität München AÖR

München, Germany

Universitätsklinikum Würzburg AÖR

Würzburg, Germany

National Cancer Center Hospital East

Chiba, Kashiwa, Japan

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, Japan

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Clínica Universidad de Navarra - Madrid

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07306559