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Clinical Trial ● Currently Recruiting Phase I NCT06190899

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

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer — Recruiting • Phase I • Oncology • NCT06190899.

📅 14 Apr 2026 ⏱ 1 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase I
NCT ID
NCT06190899
Sponsor
Celcuity Inc
Start
2024-01-01
ClinicaliQ Trial Snapshot
  • Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer — Recruiting • Phase I • Oncology • NCT06190899.
  • Treatment Being Tested: Gedatolisib (a PI3K/mTOR inhibitor) combined with darolutamide (an androgen receptor antagonist) in metastatic castration-resistant prostate cancer, with dose-finding and efficacy evaluation across Phase 1/2 stages.
  • Patient Eligibility Overview: Men with metastatic castration-resistant prostate cancer (mCRPC) who have progressed despite androgen deprivation therapy; specific inclusion/exclusion criteria determine suitability for randomization into dose cohorts.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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 Snapshot
  • Adult males ≥18 years of age 2. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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