Trials / Recruiting
RecruitingNCT06190899
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)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- Sponsor
- Celcuity Inc · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and pharmacokinetics of gedatolisib, a pan-PI3K/mTOR inhibitor, in combination with darolutamide, a next-generation androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer following progression on a next-generation androgen receptor inhibitor. The aim of the Phase 1 portion of the study is to evaluate dose limiting toxicities and to determine the recommended Phase 2 dose. The aim of the Phase 2 portion of the study is to further assess the safety and preliminary efficacy of the drug combination.
Conditions
- mCRPC (Metastatic Castration-resistant Prostate Cancer)
- Genital Diseases, Male
- Urogenital Diseases, Male
- Prostatic Disease
- Prostatic Neoplasms, Castration-Resistant
- Prostate Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gedatolisib | Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR. |
| DRUG | Darolutamide | 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. |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2028-01-01
- Completion
- 2030-01-01
- First posted
- 2024-01-05
- Last updated
- 2026-04-13
Locations
13 sites across 4 countries: United States, France, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06190899. Inclusion in this directory is not an endorsement.