Spots Global Cancer Trial Database for Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

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Trial Identification

Brief Title: Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Official Title: A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Study ID: NCT06190899

Conditions

mCRPC (Metastatic Castration-resistant Prostate Cancer)

Genital Diseases, Male

Urogenital Diseases, Male

Prostatic Disease

Prostatic Neoplasms, Castration-Resistant

Prostate Cancer

Interventions

Gedatolisib

Darolutamide

Study Description

Brief Summary: This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.

Detailed Description: This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and pharmacokinetics of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with darolutamide, a next-generation androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer following progression on a next-generation androgen receptor inhibitor. The aim of the Phase 1 portion of the study is to evaluate dose limiting toxicities and to determine the recommended Phase 2 dose. The aim of the Phase 2 portion of the study is to further assess the safety and preliminary efficacy of the drug combination.