Celcuity reports clinical data from two early phase studies of gedatolisib

Celcuity (CELC) announced preliminary clinical data for gedatolisib in two early phase clinical trials. Gedatolisib is a multi-target inhibitor that addresses all four class I PI3K isoforms and the mTOR complexes mTORC1 and mTORC2 to induce comprehensive blockade of the PI3K/AKT/mTOR pathway. Phase 1 Clinical Trial in mCRPC: In the Phase 1 portion of a clinical trial evaluating gedatolisib plus Nubeqa, an approved androgen receptor inhibitor, 38 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. In both arms, gedatolisib was administered once weekly for three weeks, then one week off. Additionally, all patients received prophylactic treatment for stomatitis. The preliminary Phase 1 data set utilized a May 30, 2025 data cut-off. The preliminary efficacy and safety analyses for the combined arms showed: The six-month rPFS was 66%. No patients discontinued treatment due to a treatment-related AE and no dose reductions were required with gedatolisib or darolutamide. No Grade 3 hyperglycemia was reported. Grade 2-3 stomatitis was reported in four patients – three Grade 2 and one Grade 3.