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RecruitingNCT07306559Updated Aug 21, 2026

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

A Phase 1 interventional study of BI 3820768 in Advanced Relapsed or Refractory Germ Cell Tumours, Advanced Relapsed or Refractory Endometrial Cancer and Advanced Relapsed or Refractory Ovarian Cancer, sponsored by Boehringer Ingelheim. Recruiting at 13 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
187
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Advanced Relapsed or Refractory Germ Cell Tumours
  • Advanced Relapsed or Refractory Endometrial Cancer
  • Advanced Relapsed or Refractory Ovarian Cancer
03

In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's planned enrollment of 187 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
187 participants (estimated)

Study arms

  • Experimental
    Part 1: BI 3820768

    Drug: BI 3820768

  • Experimental
    Part 2: BI 3820768

    Drug: BI 3820768

Interventions

  • DrugBI 3820768

    BI 3820768

06

What researchers measure

Primary outcomes

  1. Occurrence of treatment-emergent AEs

    AEs=Adverse Events

    Time frame: up to 3 years.

  2. Occurrence of DLT(s)

    DLT(s)=Dose Limiting Toxicities

    Time frame: up to 3 years.

Secondary outcomes

  1. Objective response (OR)

    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.

    Time frame: up to 3 years.

  2. Maximum measured plasma concentration of BI 3820768 after the first administration

    Time frame: up to 24 hours.

  3. Maximum measured plasma concentration of BI 3820768 after multiple administrations

    Time frame: up to 3 years.

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

    Time frame: up to 24 hours.

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

    Time frame: up to 3 years.

07

Study locations

11 of 13 sites recruiting
  • 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
    Recruiting
  • Cliniques Universitaires Saint-Luc
    Brussels, 1200, Belgium
    Recruiting
  • UZ Leuven
    Leuven, 3000, Belgium
    Suspended
  • INS Paoli-Calmettes
    Marseille, 13009, France
    Recruiting
  • Institut Gustave Roussy
    Villejuif, 94800, France
    Recruiting
  • Klinikum der Universität München AÖR
    München, 81377, Germany
    Recruiting
  • Universitätsklinikum Würzburg AÖR
    Würzburg, 97078, Germany
    Recruiting
  • National Cancer Center Hospital East
    Chiba, Kashiwa, 277-8577, Japan
    Recruiting
  • Japanese Foundation for Cancer Research
    Tokyo, Koto-ku, 135-8550, Japan
    Recruiting
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
    Recruiting
  • Clínica Universidad de Navarra - Madrid
    Madrid, 28027, Spain
    Recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No — 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07306559
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Dec 29, 2025
Start date
Feb 27, 2026
Primary completion
Sep 7, 2029 (estimated)
Completion
Jan 28, 2030 (estimated)
Last update
Aug 21, 2026

Study contacts

Boehringer Ingelheim
Contact
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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