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

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 trial tests increasing doses of BI 3820768, an immune-stimulating injection, in adults with advanced, relapsed, or refractory germ cell, endometrial, or ovarian cancer to find a tolerable dose that may shrink tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 187 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 13 sites (Los Angeles, California and 12 other locations)
• Trial ID: NCT07306559 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed advanced, relapsed, or refractory germ cell, endometrial, or ovarian cancer who have progressed after standard treatments or are not candidates for them and who meet target-positivity requirements for EC/OVC.

Not a fit: Patients who still have effective approved treatment options, who lack the required target positivity for endometrial or ovarian cancer, or who have medical issues that make trial injections unsafe are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BI 3820768 could offer a new immunotherapy option that shrinks tumors or controls disease for patients with limited or no standard treatment choices.

How similar studies have performed: This is the first time BI 3820768 is being tested in humans, so there are no direct clinical results for this drug yet, although other immune-stimulating antibodies have shown activity in some cancers.

Eligibility criteria

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 this trial is running

Los Angeles, California and 12 other locations

• Valkyrie Clinical Trials — Los Angeles, California, United States (Recruiting)
• Indiana University — Indianapolis, Indiana, United States (Not_yet_recruiting)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
• Cliniques Universitaires Saint-Luc — Brussels, Belgium (Not_yet_recruiting)
• UZ Leuven — Leuven, Belgium (Suspended)
• INS Paoli-Calmettes — Marseille, France (Not_yet_recruiting)
• Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)
• Klinikum der Universität München AÖR — München, Germany (Not_yet_recruiting)
• Universitätsklinikum Würzburg AÖR — Würzburg, Germany (Not_yet_recruiting)
• National Cancer Center Hospital East — Chiba, Kashiwa, Japan (Not_yet_recruiting)
• Japanese Foundation for Cancer Research — Tokyo, Koto-ku, Japan (Not_yet_recruiting)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (Not_yet_recruiting)
• Clínica Universidad de Navarra - Madrid — Madrid, Spain (Not_yet_recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

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