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Taking people in FrancePhase 1

Tests BI 3820768 dose tolerability in advanced germ cell, endometrial, or ovarian cancer

Tests increasing doses of BI 3820768 in adults with advanced, treatment-resistant cancers.

Key facts

Who runs it
Boehringer Ingelheim
Where
Marseille and Villejuif, FranceSee the 2 sitesAlso in 5 other countries, 10 sites
Trial code
Registry title
A Study to Test How Well Different Doses of BI 3820768 Are Tolerated by People With Advanced Cancer (Solid Tumours)
Status
Recruiting
Phase
Phase 1
People taking part
187 people, planned
Started
27 Feb 2026
Expected to end
28 Jan 2030
Type of study
Interventional, 2 groups
Treatments tested
  • BI 3820768
Record updated
21 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced germ cell tumours, endometrial cancer or ovarian cancer that came back or did not respond to treatment, and who have no remaining treatment options.

Age
18 years or older
Sex
All sexes can join
Disease stage
Advanced germ cell tumour, endometrial cancer or ovarian cancer that came back or did not respond. The disease got worse despite usual treatment, or usual treatment is not possible or not tolerated. Fit enough for daily activity (ECOG performance status 0 or 1).
Earlier treatment
People must have had usual treatment and run out of established options, or cannot take it. Major surgery within 28 days before the first dose is an exclusion.
Biomarker or test result
For endometrial and ovarian cancer, the tumour sample must test positive for the study target, checked by a central laboratory.

Main reasons for not taking part

  • Major surgery within 28 days before the first dose
  • Another cancer in the past 3 years, apart from a few effectively treated types
  • Known cancer spread to the lining of the brain and spinal cord, or spinal cord compression
  • Infection needing treatment with antimicrobial medicine within 7 days before the first dose
  • Active hepatitis C or active hepatitis B infection

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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; Further inclusion criteria apply

Who cannot take part

  • 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
  • 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)
  • 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
  • Patient with known leptomeningeal disease or spinal cord compression due to disease
  • 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

Where in France

Also in 5 other countries, 10 sites

  • Institut Paoli-CalmettesMarseille, FranceTaking people
  • Institut Gustave RoussyVillejuif, FranceTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Part 1: BI 3820768Treatment being tested

    Treatment: BI 3820768

  • Part 2: BI 3820768Treatment being tested

    Treatment: BI 3820768

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests BI 3820768 dose tolerability in advanced germ cell, endometrial, or ovarian cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 August 2026