Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Gastroenterology Diabetes / Metabolic Neurology Rheumatology Women's Health Mental Health / Psychiatry Dermatology Rare Diseases Men's Health
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
View Trial ↗
Share: Twitter/X LinkedIn
Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Guideline
Lutetium-177 vipivotide tetraxetan for treating PSMA-positive hormone-relapsed metastatic prostate cancer after an anti-androgen but not a taxane (terminated evaluation)
Oncology · 16 Jul 2026
Evaluation terminated – NICE discontinued appraisal of lutetium-177 vipivotide tetraxetan; this agent is not recommended for routine NHS use and should not…
View guideline →
Guideline
Cemiplimab for treating recurrent or metastatic cervical cancer that has progressed on or after platinum-based chemotherapy
Oncology · 09 Jul 2026
Cemiplimab is recommended as a treatment option for patients with recurrent or metastatic cervical cancer only after progression on or following platinum-based…
View guideline →
Guideline
Mirvetuximab soravtansine for treating folate receptor-alpha-positive platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer
Oncology · 24 Jun 2026
Mirvetuximab soravtansine is recommended for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients with folate receptor-alpha (FRα) positivity—confirm FRα…
View guideline →
Guideline
Imlunestrant for treating oestrogen receptor-positive HER2-negative advanced breast cancer after endocrine therapy (terminated evaluation)
Oncology · 18 Jun 2026
Imlunestrant evaluation was terminated – NICE did not complete appraisal of imlunestrant for oestrogen receptor-positive HER2-negative advanced breast cancer; clinicians should refer…
View guideline →
Guideline
Tisotumab vedotin for treating recurrent or metastatic cervical cancer that has progressed on or after systemic treatment
Oncology · 11 Jun 2026
Tisotumab vedotin is recommended for cervical cancer patients with recurrent or metastatic disease that has progressed despite prior systemic treatment—consider this as…
View guideline →
Guideline
Cemiplimab with platinum-based chemotherapy for untreated advanced non-small-cell lung cancer
Oncology · 16 Jun 2026
First-line treatment option: Cemiplimab combined with platinum-based chemotherapy is recommended by NICE for patients with untreated advanced non-small-cell lung cancer (NSCLC), offering…
View guideline →