Phase 1 Study of Oral MEN2501 for Women with Platinum-Resistant Ovarian Cancer

What this Trial Is About

Researchers are studying MEN2501, an oral drug, in adults with platinum-resistant ovarian cancer including high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This first-in-human, open-label trial aims to assess the safety, tolerability, how the drug moves through the body, its effects, and antitumor activity. The study is conducted in two parts dose escalation and dose expansionoptimization. In Part A, participants receive increasing doses of MEN2501 to evaluate dose-limiting toxicities during the first 28-day cycle. Part B focuses on determining the recommended phase 2 dose over approximately six months. The drug is given orally as tablets. The trial uses a sequential study model with randomized allocation and no masking. Participants will be monitored for treatment-emergent adverse events, tumor response rates, duration of response, clinical benefit, progression-free survival, overall survival, and drug concentration levels. These assessments occur over periods ranging from about six to twelve months. The total study duration extends to June 2028, with ongoing safety and efficacy follow-up through primary and secondary outcome measures.

A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovarian Cancer