FDA give approval for Celcuity to conduct Phase 1b/2 trial in mCRPC

Celcuity has been notified by the U.S. Food and Drug Administration,FDA, that its Investigational New Drug IND submission has been reviewed, and Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa or darolutamide , an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer, mCRPC. Celcuity’s Phase 1b/2 study or CELC-G-201, will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor as first-line treatment for mCRPC. The Company anticipates initiating this Phase 1b/2 clinical trial in the first quarter of 2024. “We are excited to initiate the clinical development of gedatolisib in prostate cancer,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity. “Gedatolisib’s highly differentiated mechanism of action makes it uniquely suited to address the complex PI3K/mTOR activity involved in this disease.” In the Phase 1b portion of the study, Celcuity expects that 36 participants will be randomly assigned to receive 600 mg darolutamide combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. An additional 12 participants will then be enrolled in the Phase 2 portion of the study at the RP2D level to enable evaluation of 30 participants treated with the RP2D of gedatolisib. The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of the recommended Phase 2 dose of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic progression-free survival rPFS at six months of patients who received the RP2D.