Different doses of BI 3820768 for adults with advanced germ cell, endometrial, or ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, first-in-human dose-escalation trial enrolls adults with advanced, relapsed, or refractory germ cell tumors, endometrial cancer, or ovarian cancer who have exhausted or are not candidates for standard therapies. Participants receive BI 3820768 by injection in one of two administration schedules, with weekly injections for two 3-week cycles followed by dosing every three weeks. The primary aim is to find a tolerable dose and recommended dose for future studies while closely monitoring safety, side effects, and drug behavior in the body; tumor responses will also be recorded. Participants who benefit may remain on treatment for up to three years.

Why it matters

Who can join: the full rules

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.

Where it's running

• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• Cliniques Universitaires Saint-Luc
  Brussels, Belgium Recruiting
• INS Paoli-Calmettes
  Marseille, France Recruiting
• Institut Gustave Roussy
  Villejuif, France Recruiting
• Klinikum der Universität München AÖR
  München, Germany Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.