Phase 1 Study of Valemetostat and Darolutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

The primary objective is to evaluate the safety and tolerability of the combination of valemetostat and darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). Determining the safety profile of this therapeutic combination is clinically essential for establishing the feasibility of subsequent clinical development.

This clinical trial involves 47 male participants diagnosed with metastatic castration-resistant prostate cancer. The study population consists of patients within the age range corresponding to codes 3 and 4. The sponsor did not provide additional information regarding selection processes, lifestyle considerations, or specific inclusion and exclusion criteria.

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of valemetostat and darolutamide in patients diagnosed with metastatic castration-resistant prostate cancer. The study follows a specific research methodology to assess the therapeutic impact of the combination treatment. The clinical process begins with a screening visit to determine eligibility based on predefined criteria. Following successful enrollment, participants will undergo scheduled follow-up visits to monitor clinical responses and safety parameters. The sequence concludes with an end-of-study visit. The overall duration of the trial is estimated to extend from April 2026 to June 2030. Participation may be discontinued prior to the scheduled completion if specific clinical criteria or safety protocols necessitate early termination.

The assessment of efficacy in this phase 3 clinical trial for metastatic castration-resistant prostate cancer is not specified in the provided source material.