Celcuity announces first patient dosed in Phase 1b/2 CELC-G-201 clinical trial

Celcuity announced that the first patient has been dosed in its Phase 1b/2 study evaluating gedatolisib in combination with Nubeqa, an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer. Gedatolisib, the company’s lead therapeutic candidate, is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTORC1/2. “We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer,” said Igor Gorbatchevsky, M.D. Chief Medical Officer of Celcuity. “A significant unmet need remains for patients with metastatic castration resistant prostate cancer who have become resistant to a next generation androgen receptor inhibitor.” In August 2023, Celcuity announced that it had entered into a clinical trial collaboration and supply agreement with Bayer AG to provide Nubeqa to Celcuity at no cost for the Phase 1b/2 trial.