Prostate Cancer
A Phase 1/2 clinical trial evaluating gedatolisib for patients with metastatic castration resistant prostate cancer
The CELC-G-201 Phase 1/2 clinical trial is evaluating gedatolisib plus darolutamide, an androgen receptor (AR) inhibitor, in patients previously treated with an AR inhibitor for metastatic castration resistant prostate cancer (mCRPC).
Approximately 48 to 54 eligible patients will be enrolled.
In the Phase 1 portion of the study, 18 participants will be randomly assigned to each of 2 dose arms (n = 36 total) and evaluated in two parts. Arm 1 will evaluate 120 mg gedatolisib, and Arm 2 will evaluate 180 mg gedatolisib.
In the Phase 2 study, an additional 12 participants will then be enrolled at the recommended Phase 2 dose (RP2D) level. The total number of participants will be approximately 48 to 54, with 30 participants enrolled at the RP2D level.
Key eligibility criteria
- Metastatic castration resistant prostate cancer
- Prior treatment with an AR inhibitor
- No prior treatment with AKT, PI3K, mTOR inhibitors
- No prior chemotherapy for mCPRC
Key endpoints
- Safety
- Recommended Phase 2 dose
- Radiographic progression-free survival at six months
- Radiographic progression-free survival at 12 months
- Overall response rate
Study locations
CELC-G-201 is being conducted at sites in the United States and Europe.