Celcuity(US:CELC) Globenewswire·2025-10-18 08:30Core Insights - Celcuity Inc. announced updated clinical results from a Phase 1 trial evaluating gedatolisib in combination with darolutamide for men with metastatic castration-resistant prostate cancer (mCRPC) [1][5] Group 1: Clinical Trial Details - The Phase 1 study involved 38 patients with mCRPC, randomly assigned to receive either 120 mg or 180 mg of gedatolisib alongside 600 mg of darolutamide twice daily [2] - The median duration of follow-up for the trial was 9.0 months, with 61% of patients having received one line of prior systemic therapy and 39% having received two or more lines [2] Group 2: Efficacy Results - The combined six-month radiographic progression-free survival (rPFS) rate was 67%, with a median rPFS of 9.1 months [3][7] - For the 120 mg gedatolisib group, the six-month rPFS rate was 74% and median rPFS was 9.5 months, while for the 180 mg group, the rates were 61% and 7.4 months, respectively [3] Group 3: Safety Profile - The combination therapy was generally well tolerated, with mostly low-grade treatment-related adverse events (TRAEs) [4] - No dose-limiting toxicities were observed, and the only Grade 3 TRAEs reported were rash (5.3%), stomatitis (2.6%), and pruritus (2.6%) [4] Group 4: Future Plans - The company is enrolling patients in an updated Phase 1/1b trial to determine the recommended Phase 2 dose, with plans to enroll up to six patients in each of three arms [5] - Following the Phase 1 completion, an additional 40 patients will be randomly assigned to four Phase 1b cohorts to establish the recommended Phase 2 dose [5]