Actively Recruiting
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
Led by Celcuity Inc · Updated on 2026-04-13
54
Participants Needed
13
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult males 18 years or older
- Confirmed diagnosis of prostate adenocarcinoma without small cell component and less than 10% neuroendocrine cells
- Diagnosed with metastatic castration-resistant prostate cancer (mCRPC)
- Metastatic disease identified by CT, MRI, or bone scan; PSMA PET-only metastases not allowed
- Progressive mCRPC based on PSA rise, soft-tissue growth, or new bone lesions as per defined criteria
- Continuing primary androgen deprivation therapy unless surgically castrated
- ECOG performance status score of 0 or 1
- Progression during treatment with one next-generation androgen receptor signaling inhibitor
- Completed prior androgen receptor inhibitor treatment at least 4 weeks before study drug
- At least 2 weeks since targeted therapy or major surgery, and 3 weeks since other systemic or radiation therapy, with toxicities resolved to baseline except mild ones
- Adequate bone marrow, liver, kidney, and blood clotting function
You will not qualify if you...
- History of other cancers except non-melanoma skin cancer or other solid tumors treated with no disease for 3 or more years
- Prostate adenocarcinoma with small cell component or 10% or more neuroendocrine cells
- Prior treatment with PI3K, AKT, or mTOR inhibitors
- Prior chemotherapy or radiopharmaceutical therapy for mCRPC (except chemotherapy plus ADT for castration-sensitive disease)
- Uncontrolled type 1 or type 2 diabetes
- Known untreated or active brain or leptomeningeal metastases; treated CNS metastases allowed if stable and not requiring steroids or seizures
- History of serious cardiovascular problems
- Gastrointestinal diseases causing inability to absorb oral medication or history of inflammatory bowel disease
- Unable to swallow oral medication tablets or capsules
- Other criteria as specified in the study protocol regarding safety and treatment history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
2
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
3
Institut Paoli-Calmettes
Marseille, France, 13009
Not Yet Recruiting
4
Centre Antoine Lacassagne
Nice, France, 06100
Not Yet Recruiting
5
Institut Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
6
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Actively Recruiting
7
Institut Catala d'Oncologia
Barcelona, Spain, 08908
Actively Recruiting
8
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Not Yet Recruiting
9
Hospital 12 de Octubre
Madrid, Spain, 28045
Actively Recruiting
10
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Not Yet Recruiting
11
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospita
Cambridge, United Kingdom, CB20QQ
Not Yet Recruiting
12
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Not Yet Recruiting
13
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM25PT
Actively Recruiting
Research Team
G
Genelle Brower, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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