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The COSMYC Trial (COmbined Suppression of MYC)

NCT06922318 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-17

No results posted yet for this study

Summary

This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.

Conditions

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.

Sponsors & Collaborators

  • Zenith Epigenetics

    collaborator INDUSTRY

  • National Cancer Institute (NCI)

    collaborator NIH

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Samuel Denmeade, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-19
Primary Completion
2031-08-30
Completion
2031-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT06922318 on ClinicalTrials.gov