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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Celcuity Inc
Study ID
NCT06190899
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Genital Diseases, Male
  • Prostate Cancer
  • Prostatic Disease
  • Prostatic Neoplasms, Castration-Resistant
  • Urogenital Diseases, Male
  • mCRPC (Metastatic Castration-resistant Prostate Cancer)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gedatolisib — DRUG
    Gedatolisib is a potent reversible inhibitor that selectively targets all Class I PI3K isoforms and mTOR.
  • Darolutamide — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Apr 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2030

Study Design

Enrollment
54 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Arm 1
    Arm 1 - 120 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)
  • Experimental: Phase 1 Arm 2
    Arm 2 - 180 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)
  • Experimental: Phase 2
    The recommended Phase 2 dose (RP2D) of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)

Primary Outcome Measure

Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) [ Time Frame: Cycle 1, Day 1 to end of safety follow up (each cycle is 28 days and safety follow up will continue until 30 days after last dose of study medication) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-

Find similar trials in Detroit, MI

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Barbara Ann Karmanos Cancer Institute· Detroit, MI

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