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

NCT06190899

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • mCRPC (Metastatic Castration-resistant Prostate Cancer)
  • Genital Diseases, Male
  • Urogenital Diseases, Male
  • Prostatic Disease
  • Prostatic Neoplasms, Castration-Resistant
  • Prostate Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
Male
Healthy volunteers
Not accepted
Sponsor
Celcuity Inc
Last updated on ClinicalTrials.gov
April 13, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Michigan · 1

  • Barbara Ann Karmanos Cancer Institute · Detroit, MI

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.