RecruitingPhase 2NCT06922318

The COSMYC Trial (COmbined Suppression of MYC)

A Phase II Study of Sequential Bipolar Androgen Therapy and ZEN-3694 in Sequence With Enzalutamide + ZEN-3694 in Asymptomatic Patients With Metastatic CRPC: The COSMYC Trial (COmbined Suppression of MYC)

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

50 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Castration-resistant Prostate Cancer

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination for men with metastatic prostate cancer that has stopped responding to hormone therapy and a second-generation anti-androgen drug (like enzalutamide or abiraterone). The drugs being tested target a protein called MYC that helps cancer cells grow. **You may be eligible if...** - You have confirmed metastatic prostate cancer - Your cancer has progressed while on androgen deprivation therapy (hormone therapy) AND on a second-generation anti-androgen drug - Your testosterone levels are castrate-level low - You have measurable disease on imaging - Your overall health is adequate **You may NOT be eligible if...** - Your cancer has not progressed after hormone therapy - You have had prior treatment with certain targeted drugs - You have significant heart disease or other serious health conditions - You are unable to swallow oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZEN-3694

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

DRUGTestosterone cypionate

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

DRUGEnzalutamide

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

DRUGLuteinizing 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.