A clinical trial, known as CELC-G-201, is exploring a new treatment approach for men with metastatic castration-resistant prostate cancer (mCRPC).

The study, currently in Phase 1/1b/2, combines gedatolisib, a drug that inhibits the PI3K/AKT/mTOR pathway, with darolutamide, an established androgen receptor inhibitor. The goal is to evaluate whether this dual approach can improve outcomes for patients who have few options left after standard treatments fail.
The trial has enrolled 38 patients so far, with plans to include up to 46 more in Phase 1 and approximately 30 in Phase 2, some of whom may be prior participants.

Early results from the Phase 1 portion show a 6-month radiographic progression-free survival rate of 66%, meaning two-thirds of patients had no disease progression on imaging after six months. This suggests the combination may help delay cancer growth, though longer-term data are needed. The trial also tracks progression-free survival at 9 and 12 months and overall survival at 18 and 24 months to better understand the treatment’s impact. Safety data are encouraging. No patients have stopped treatment or needed dose reductions due to side effects.

The trial is being conducted across multiple sites in the United States, United Kingdom, France, and Spain, ensuring a diverse patient group. It began dosing its first patient in February 2024 and is expected to continue until November 2027, when final results will provide a clearer picture of the treatment’s potential.

Clinical trial.