Phase 12 Study of Gedatolisib Combined With Darolutamide for Treating Metastatic Castration-Resistant Prostate Cancer in Adult Men

What this Trial Is About

Researchers are evaluating the safety, early effectiveness, and how the body processes gedatolisib combined with darolutamide in men with metastatic castration-resistant prostate cancer mCRPC. This study includes both dose-finding and dose-expansion phases to better understand the best dosing and initial treatment effects of these drugs in patients who have progressed on existing androgen receptor inhibitors. Gedatolisib targets specific enzymes involved in cancer growth, while darolutamide is a next-generation androgen receptor inhibitor. Participants receive one of two doses of gedatolisib 120 mg or 180 mg given once weekly for three weeks followed by one week off, along with darolutamide 600 mg taken orally twice daily during 28-day cycles. The study is divided into Phase 1, focused on finding dose-limiting toxicities and the recommended dose for Phase 2, and Phase 2, which further assesses safety and preliminary effectiveness of the drug combination. During the study, participants will undergo regular safety assessments, including monitoring for side effects and measuring antitumor activity through imaging tests. The primary outcomes include safety and tolerability in Phase 1 and radiographic progression-free survival in Phase 2. The study also tracks pharmacokinetics and other measures of the drugs effects. Follow-up safety monitoring continues for 30 days after the last dose, and participant involvement may last for about one year or longer depending on study phase and outcomes.

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer