Celcuity Inc. Reports Clinical Data from Two Early Phase Studies of Gedatolisib

Published: 2025-06-30 07:50:23 ET CELC

Published on 06/30/2025 at 07:50

Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials. In the Phase 1 portion of a clinical trial evaluating gedatolisib plus Nubeqa®? (darolutamide), 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 gedatoliib in Arm 2. Additional preliminary results for the Phase 1 portion of the clinical trial will be presented at a medical conference later this year.

With no treatment-related discontinuations and less than 3% of patients experiencing Grade 3 stomatitis, the company believe it is important to explore additional dose options for gedatolisib. Available gedatolisib pharmacokinetic (PK) data from other clinical trials in solid tumors suggests a relationship between efficacy and dose levels. Since this preliminary data indicates that the optimal gedatolisib dose for patients with mCRPC may not yet have been reached, the company amended the clinical trial protocol to enable exploration of additional doses in the Phase 1/1b portion of this clinical trial to determine the recommended Phase 2 dose." In the amended Phase 1 portion of the clinical trials, up to six patients are planned to be enrolled in each of three arms and treated with different doses.

Dose levels will be selected based on the results from the Phase 1 clinical trial. In the Phase 2 dose expansion study, which will include subjects from the Phase 1/1b clinical trial, up to 18 additional subjects will be enrolled to achieve a total of approximately 30 subjects treated with the RP2D. In this investigator-sponsored Phase 2 clinical trial, 44 patients with HER2+/PIK3CA mutated mBC were treated with gedatolisib plus standard doses of trastuzumab-pkrb.

A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatoliib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial the VIKTORIA-2, evaluating gedatolisIB plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER 2- advanced breast cancer is currently recruiting patients.