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Study identifier: NCT06190899 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: mCRPC (Metastatic Castration-resistant Prostate Cancer) · Genital Diseases, Male · Urogenital Diseases, Male  ·  Sponsor: Celcuity Inc

PhasePhase 1/Phase 2
Planned participants54
Who can joinMale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Genelle Brower, RN  ·  844-310-3900  ·  gbrower@celcuity.com

Always discuss trial participation with your own doctor first.

Locations (13)

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan, United StatesRecruiting
Centre Jean PerrinClermont-Ferrand, FranceNot Yet Recruiting
Institut Paoli-CalmettesMarseille, FranceNot Yet Recruiting
Centre Antoine LacassagneNice, FranceNot Yet Recruiting
Institut Gustave RoussyVillejuif, FranceNot Yet Recruiting
Hospital Clinic BarcelonaBarcelona, SpainRecruiting
Institut Catala d'OncologiaBarcelona, SpainRecruiting
Hospital General Universitario Gregorio MaranonMadrid, SpainNot Yet Recruiting
Hospital 12 de OctubreMadrid, SpainRecruiting
Instituto Valenciano de OncologíaValencia, SpainNot Yet Recruiting
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's HospitaCambridge, United KingdomNot Yet Recruiting
University Hospital Southampton NHS Foundation Trust - Southampton General HospitalSouthampton, United KingdomNot Yet Recruiting

+ 1 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06190899