OncoMatch/Clinical Trials/NCT06190899
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
Is NCT06190899 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Gedatolisib and Darolutamide for mcrpc (metastatic castration-resistant prostate cancer).
Treatment: Gedatolisib · Darolutamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: androgen receptor signaling inhibitor (abiraterone, enzalutamide, apalutamide, darolutamide) — metastatic disease
Progression during treatment with one next-generation androgen receptor signaling inhibitor for metastatic disease (e.g., abiraterone, enzalutamide, apalutamide, darolutamide)
Cannot have received: PI3K inhibitor
Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor
Cannot have received: AKT inhibitor
Prior treatment with a protein kinase B (AKT) inhibitor
Cannot have received: mTOR inhibitor
Prior treatment with a mechanistic target of rapamycin (mTOR) inhibitor
Cannot have received: chemotherapy
Exception: except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide
Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide)
Cannot have received: radiopharmaceutical therapy
Exception: except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide
Prior treatment with chemotherapy or radiopharmaceutical therapy for mCRPC (except prior chemotherapy plus ADT for castration-sensitive disease, including docetaxel plus darolutamide)
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Barbara Ann Karmanos Cancer Institute · Detroit, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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