The COSMYC Trial (COmbined Suppression of MYC)

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 19, 2025

Primary Completion Date

August 30, 2031

Study Completion Date

August 30, 2031

Conditions
Metastatic Castration-resistant Prostate Cancer
Interventions
DRUG

ZEN-3694

One ZEN-3694 pill (48 mg) will be taken each day of each BATZEN cycle.

DRUG

Testosterone cypionate

On day 1 of each BATZEN cycle testosterone cypionate (400 mg) injection to the buttocks will be administered.

DRUG

Enzalutamide

Enzalutamide 160 mg (four 40 mg capsules) taken daily by mouth on each ZENZA cycle.

DRUG

Luteinizing hormone-releasing hormone (LHRH) analogue

Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout the duration of the study to inhibit endogenous testosterone production.

Trial Locations (1)

21205

RECRUITING

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Zenith Epigenetics

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER