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

Description

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

Study Overview

Study Details

Study overview

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.

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)

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

Condition
mCRPC (Metastatic Castration-resistant Prostate Cancer)
Intervention / Treatment

-

Contacts and Locations

Detroit

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    MALE

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Celcuity Inc,

    Nadene Zack, MS, STUDY_DIRECTOR, Celcuity Inc

    Study Record Dates

    2027-11