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

NCT06190899 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Celcuity Inc

    lead INDUSTRY

Principal Investigators

  • Nadene Zack, MS · Celcuity Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2028-01-31
Completion
2030-01-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06190899 on ClinicalTrials.gov