First Patient Receives Gedatolisib in Phase 1b/2 Trial for mCRPC Treatment

Biotechnology firm Celcuity Inc., listed on Nasdaq as CELC, has initiated a Phase 1b/2 clinical trial, known as CELC-G-201, to test the efficacy and safety of gedatolisib combined with Nubeqa® (darolutamide) for metastatic castration-resistant prostate cancer (mCRPC) patients. Gedatolisib is a targeted therapy that inhibits specific PI3K isoforms and mTORC1/2, addressing an unmet need for patients resistant to current androgen receptor inhibitors.
Dr. Igor Gorbatchevsky, Celcuity's Chief Medical Officer, expressed enthusiasm about the trial's potential to offer a novel treatment option. The study is led by Professor Karim Fizazi, who highlights the scientific rationale behind combining PAM inhibitors with next-generation androgen receptor therapies. Celcuity has partnered with Bayer AG, which is supplying Nubeqa® for the trial without charge.
The trial aims to enroll 54 mCRPC patients who have seen disease progression after treatment with an androgen receptor inhibitor. It consists of two phases: Phase 1b, which will assess the safety and determine the optimal dose of gedatolisib, and Phase 2, which will evaluate the radiographic progression-free survival of patients at six months.
Celcuity is dedicated to developing targeted therapies for various solid tumors, with gedatolisib as its lead candidate. The company is also conducting the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer. Celcuity's CELsignia diagnostic platform helps identify patients likely to benefit from targeted therapies. 

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!