A Phase I Dose-Escalation Study to Evaluate the Safety and Tolerability of BI 3820768 in Patients with Advanced Relapsed or Refractory Ovarian, Endometrial, or Germ Cell Tumors

The primary objective of this study is to evaluate the tolerability of various doses of BI 3820768 in patients diagnosed with advanced relapsed or refractory ovarian cancer, endometrial cancer, or germ cell tumours. Establishing the dose-toleration profile is essential for determining safe administration protocols in patients with solid tumours. Scope: 9.

This clinical trial involves 75 patients. The study population consists of both female and male individuals. Participants are categorized within specific age ranges. The subjects are diagnosed with advanced relapsed or refractory ovarian cancer, advanced relapsed or refractory endometrial cancer, or advanced relapsed or refractory germ cell tumours.

This Phase 3 clinical trial is designed to evaluate the tolerability of various doses of BI 3820768 in patients diagnosed with advanced relapsed or refractory ovarian cancer, advanced relapsed or refractory endometrial cancer, or advanced relapsed or refractory germ cell tumours. The research methodology involves a systematic assessment of dose levels to determine safety profiles within these specific solid tumours. The study sequence begins with a screening visit to determine eligibility. Following inclusion, participants will attend scheduled follow-up visits to monitor clinical responses and safety. The process concludes with an end-of-study visit. The total duration of the trial is estimated to span from April 2026 to June 2029. Participation may be subject to early termination based on predefined clinical conditions or safety protocols.

The efficacy assessment for this Phase 3 clinical trial focuses on patients diagnosed with advanced relapsed or refractory ovarian cancer, advanced relapsed or refractory endometrial cancer, or advanced relapsed or refractory germ cell tumours.