RecruitingPhase 1Phase 2NCT06190899

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

A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)


Sponsor

Celcuity Inc

Enrollment

54 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — gedatolisib (a PI3K/mTOR inhibitor) and darolutamide (a hormone-blocking drug) — for men with prostate cancer that has spread and is no longer responding to standard hormone therapy (castration-resistant prostate cancer). **You may be eligible if...** - You are a man (18 or older) with metastatic prostate cancer that progressed despite standard hormone-suppressing treatments - Your cancer has been confirmed by standard imaging (CT, MRI, or bone scan) - Your PSA level is at least 1.0 ng/mL and has been rising - Your general health (ECOG 0–1) and organ function meet study requirements **You may NOT be eligible if...** - Your cancer has only been detected on a PSMA PET scan (not visible on standard imaging) - You have significant heart disease (NYHA class III or IV) - You have a small-cell or neuroendocrine component to your prostate cancer (>10%) - You have uncontrolled diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGedatolisib

Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR.

DRUGDarolutamide

Darolutamide is a novel androgen receptor inhibitor that has been studied and received approval for treatment of patients with nonmetastatic CRPC and in metastatic hormone-sensitive prostate cancer.


Locations(13)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Centre Jean Perrin

Clermont-Ferrand, France

Institut Paoli-Calmettes

Marseille, France

Centre Antoine Lacassagne

Nice, France

Institut Gustave Roussy

Villejuif, France

Hospital Clinic Barcelona

Barcelona, Spain

Institut Catala d'Oncologia

Barcelona, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital 12 de Octubre

Madrid, Spain

Instituto Valenciano de Oncología

Valencia, Spain

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita

Cambridge, United Kingdom

University Hospital Southampton NHS Foundation Trust - Southampton General Hospital

Southampton, United Kingdom

Royal Marsden NHS Foundation Trust

Sutton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06190899


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