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

May 26, 2026 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

187

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Not yet recruiting
        • Cliniques universitaires Saint-Luc
        • Contact:
      • Leuven, Belgium, 3000
        • Suspended
        • UZ Leuven
  • France
      • Marseille, France, 13009
        • Not yet recruiting
        • INS Paoli-Calmettes
        • Contact:
      • Villejuif, France, 94800
        • Not yet recruiting
        • Institut Gustave Roussy
        • Contact:
  • Germany
      • München, Germany, 81377
        • Not yet recruiting
        • Klinikum der Universität München AÖR
        • Contact:
      • Würzburg, Germany, 97078
        • Not yet recruiting
        • Universitätsklinikum Würzburg AÖR
        • Contact:
  • Japan
      • Chiba, Kashiwa, Japan, 277-8577
        • Not yet recruiting
        • National Cancer Center Hospital East
        • Contact:
      • Tokyo, Koto-ku, Japan, 135-8550
        • Not yet recruiting
        • Japanese Foundation for Cancer Research
        • Contact:
  • Spain
      • Barcelona, Spain, 08035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
        • Contact:
      • Madrid, Spain, 28027
        • Not yet recruiting
        • Clinica Universidad de Navarra - Madrid
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 90067
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria :

  1. Patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the informed consent forms (ICFs).
  2. For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated written ICF1 for target testing.
  3. Signed and dated ICF2 for all patients describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.
  4. Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on central laboratory testing of tumour tissue sample.
  5. Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour (GCT), EC, or OVC.
  6. Patients with advanced, relapsed/refractory (r/r) GCT, EC, or OVC.
  7. Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, who have exhausted all established treatment options.
  8. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Further inclusion criteria apply.

Exclusion criteria:

  1. Patient with a history of a major surgery within 28 days prior to the first dose of BI 3820768 (major according to the Investigator's and/or Sponsor's assessment).

  2. Previous or concomitant malignancies other than the one treated in this trial within the past 3 years except:

    1. Effectively treated non-melanoma skin cancers
    2. Effectively treated carcinoma in situ of the cervix
    3. Effectively treated ductal carcinoma in situ
    4. Other effectively treated malignancy that is considered cured by local treatment
  3. Patient with known leptomeningeal disease or spinal cord compression due to disease.
  4. Presence of any infection requiring systemic antimicrobial treatment within 7 days prior to the first dose of trial medication. Patients who have any clinical signs of infection (e.g. fever or leukocytosis) within 48 h prior to the first dose of trial medication are not eligible.

  5. Patients with Hepatitis-C-Virus (HCV) infection, defined as:

    1. Currently receiving curative antiviral treatment for HCV infection, and/or
    2. HCV viral load is above the limit of quantification (HCV RNA positive).
  6. Patients with active hepatitis B virus (HBV) infection (chronic or acute); defined as having a positive hepatitis B surface antigen (HBsAg), and HBsAg test at screening.
  7. Patient with past HBV infection or resolved HBV infection (defined as the presence of hepatitis B core antibody (HBcAb) and absence of HbsAg) are eligible. HBV DNA must be obtained in these patients prior study start.

Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: BI 3820768
Drug: BI 3820768
BI 3820768
Experimental: Part 2: BI 3820768
Drug: BI 3820768
BI 3820768

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of treatment-emergent AEs
Time Frame: up to 3 years.
AEs=Adverse Events
up to 3 years.
Occurrence of DLT(s)
Time Frame: up to 3 years.
DLT(s)=Dose Limiting Toxicities
up to 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response (OR)
Time Frame: up to 3 years.
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.
up to 3 years.
Maximum measured plasma concentration of BI 3820768 after the first administration
Time Frame: up to 24 hours.
up to 24 hours.
Maximum measured plasma concentration of BI 3820768 after multiple administrations
Time Frame: up to 3 years.
up to 3 years.
Area under the concentration-time curve of BI 3820768 after the first administration
Time Frame: up to 24 hours.
up to 24 hours.
Area under the concentration-time curve of BI 3820768 after multiple administrations
Time Frame: up to 3 years.
up to 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2026

Primary Completion (Estimated)

April 21, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001-0001
  • 2025-522913-45-00 (Registry Identifier: CTIS (EU))
  • U1111-1324-5961 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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