Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

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.

Trial Details

NCT ID

NCT06190899

Phase

PHASE1 / PHASE2

Sponsor

Celcuity Inc

Status

RECRUITING

Cancer Type

Hormone-Sensitive Prostate Cancer

Interventions

Gedatolisib
Darolutamide

Locations (sample)

Detroit, Michigan, United States|42.33143,-83.04575
Clermont-Ferrand, France|45.77969,3.08682
Marseille, France|43.29695,5.38107
Nice, France|43.70313,7.26608
Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

Adult males ≥18 years of age
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with \<10% neuroendocrine …
Subjects must have metastatic castration-resistant prostate cancer (mCRPC; i.e., developed progression of metastases following surgical castration …
Metastatic disease identified by conventional imaging: computed tomography (CT), magnetic resonance imaging (MRI), or technetium 99m-methyl diphosp…

For full eligibility, visit ClinicalTrials.gov.

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