Actively Recruiting
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
Led by Celcuity Inc · Updated on 2026-04-13
54
Participants Needed
13
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, early effectiveness, and how the body processes gedatolisib combined with darolutamide in men with metastatic castration-resistant prostate cancer (mCRPC). This study includes both dose-finding and dose-expansion phases to better understand the best dosing and initial treatment effects of these drugs in patients who have progressed on existing androgen receptor inhibitors. Gedatolisib targets specific enzymes involved in cancer growth, while darolutamide is a next-generation androgen receptor inhibitor. Participants receive one of two doses of gedatolisib (120 mg or 180 mg) given once weekly for three weeks followed by one week off, along with darolutamide 600 mg taken orally twice daily during 28-day cycles. The study is divided into Phase 1, focused on finding dose-limiting toxicities and the recommended dose for Phase 2, and Phase 2, which further assesses safety and preliminary effectiveness of the drug combination. During the study, participants will undergo regular safety assessments, including monitoring for side effects and measuring antitumor activity through imaging tests. The primary outcomes include safety and tolerability in Phase 1 and radiographic progression-free survival in Phase 2. The study also tracks pharmacokinetics and other measures of the drugs’ effects. Follow-up safety monitoring continues for 30 days after the last dose, and participant involvement may last for about one year or longer depending on study phase and outcomes.
CONDITIONS
Brief 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 of age or older
- Confirmed diagnosis of adenocarcinoma of the prostate without small cell component and less than 10% neuroendocrine cells
- Metastatic castration-resistant prostate cancer with progression after surgical or medical castration
- Metastatic disease confirmed by CT, MRI, or bone scan (measurable or non-measurable disease allowed)
- Progressive disease based on PSA rise, soft tissue growth, or new bone lesions
- Continued primary androgen deprivation therapy if no surgical castration
- ECOG performance status of 0 or 1
- Disease progression during treatment with one next-generation androgen receptor 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 anticancer or radiation therapy, with recovery of side effects
- Adequate bone marrow, liver, kidney, and coagulation function
You will not qualify if you...
- History of other cancers unless cured and disease-free 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 metastatic castration-resistant prostate cancer (except prior chemotherapy for castration-sensitive disease)
- Uncontrolled type 1 or type 2 diabetes
- Known untreated or active brain or leptomeningeal metastases (stable treated CNS metastases allowed)
- Significant cardiovascular problems
- Gastrointestinal conditions preventing oral medication absorption or history of inflammatory bowel disease
- Inability to swallow oral tablets or capsules
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive gedatolisib once weekly for 3 weeks on followed by 1 week off, in combination with darolutamide taken orally twice daily in 28-day cycles.
Visits occur regularly during each 28-day cycle for treatment administration and monitoring
Duration - At least 30 days after last dose of study medication
Participants are monitored for safety and preliminary efficacy after completing treatment.
Approximately 1 follow-up visit after treatment ends
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
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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