OncoMatch/Clinical Trials/NCT06190899
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
Is NCT06190899 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Endocrine / hormonal
Other
Cancer type
Prostate Cancer
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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 →Frequently asked questions
Is NCT06190899 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PI3K inhibitor, AKT inhibitor, mTOR inhibitor disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages