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

NCT07306559 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 2001-00012025-522913-45-00U1111-1324-5961
• Study Type: interventional
• Target: 187
• Locations: 6 countries
• Sites: 13

Brief 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

Advanced Relapsed or Refractory Endometrial Cancer; Advanced Relapsed or Refractory Germ Cell Tumours; Advanced Relapsed or Refractory Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• Occurrence of treatment-emergent AEs

  AEs=Adverse Events

  up to 3 years.

• Occurrence of DLT(s)

  DLT(s)=Dose Limiting Toxicities

  up to 3 years.

Secondary Outcomes (5)

• Objective response (OR)

  up to 3 years.

• Maximum measured plasma concentration of BI 3820768 after the first administration

  up to 24 hours.

• Maximum measured plasma concentration of BI 3820768 after multiple administrations

  up to 3 years.

• Area under the concentration-time curve of BI 3820768 after the first administration

  up to 24 hours.

• Area under the concentration-time curve of BI 3820768 after multiple administrations

  up to 3 years.

Study Arms (2)

Part 1: BI 3820768

EXPERIMENTAL

Drug: BI 3820768

Part 2: BI 3820768

EXPERIMENTAL

Drug: BI 3820768

Interventions

BI 3820768 DRUG

BI 3820768

Part 1: BI 3820768; Part 2: BI 3820768

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• For patients with endometrial cancer (EC) and ovarian cancer (OVC), signed and dated written ICF1 for target testing.
• 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.
• Prior to Screening Visit 02, confirmed target-positivity for EC and OVC based on central laboratory testing of tumour tissue sample.
• Patients with a histologically or cytologically confirmed diagnosis of germ cell tumour (GCT), EC, or OVC.
• Patients with advanced, relapsed/refractory (r/r) GCT, EC, or OVC.
• Patients with disease progression despite conventional treatment, intolerant to or not a candidate for conventional treatment, who have exhausted all established treatment options.
• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

• 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).
• Previous or concomitant malignancies other than the one treated in this trial within the past 3 years except:
• Effectively treated non-melanoma skin cancers
• Effectively treated carcinoma in situ of the cervix
• Effectively treated ductal carcinoma in situ
• Other effectively treated malignancy that is considered cured by local treatment
• Patient with known leptomeningeal disease or spinal cord compression due to disease.
• 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.
• Patients with Hepatitis-C-Virus (HCV) infection, defined as:
• Currently receiving curative antiviral treatment for HCV infection, and/or
• HCV viral load is above the limit of quantification (HCV RNA positive).
• 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.
• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

Valkyrie Clinical Trials

Los Angeles, California, 90067, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

NOT YET RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

NOT YET RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

SUSPENDED

INS Paoli-Calmettes

Marseille, 13009, France

NOT YET RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

NOT YET RECRUITING

Klinikum der Universität München AÖR

München, 81377, Germany

NOT YET RECRUITING

Universitätsklinikum Würzburg AÖR

Würzburg, 97078, Germany

NOT YET RECRUITING

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

NOT YET RECRUITING

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, 135-8550, Japan

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Clínica Universidad de Navarra - Madrid

Madrid, 28027, Spain

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Endometrial Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): September 7, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); JP (2); ES (2); FR (2); DE (2); BE (2)