The COSMYC Trial (COmbined Suppression of MYC)

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT06922318
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZEN-3694 — DRUG
    ZEN-3694 is available in two capsule strengths for this study: 12 mg and 48 mg.
  • Testosterone cypionate — DRUG
    On day 1 of each BATZEN cycle testosterone cypionate (400 mg) injection to the buttocks will be administered.
  • Enzalutamide — DRUG
    Enzalutamide 160 mg (four 40 mg tablets) taken daily by mouth on each ZENZA cycle.
  • Luteinizing hormone-releasing hormone (LHRH) analogue — DRUG
    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.

Study Details

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.

Key Dates

First listed
Apr 10, 2025
Start date
Aug 19, 2025
Status verified
Jun 2026
Primary completion
Aug 30, 2031
Completion
Aug 30, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BATZEN
    ZEN-3694 36 mg (3 x 12 mg capsules) will be taken once per day by mouth each cycle (each cycle is 28 days). On the first day of each cycle, testosterone cypionate (400 mg) injection will be administered into the buttocks. The participant will continue with additional 28-day cycles of ZEN-3694 pills and testosterone injections until there is disease progression on bone and CT scans.
  • Experimental: ZENZA
    ZENZA cycles will begin once there is disease progression on bone and CT scans. ZEN-3694 dose will increase to 72 mg (one 48 mg and two 12 mg tablets) to be taken daily by mouth. Enzalutamide 160 mg (four 40 mg tablets) will be taken daily by mouth.

Primary Outcome Measure

Clinical/radiographic progression free survival (PFS) with BATZEN [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21205
Samuel Denmeade, MD
[email protected]
410-733-3232

Find similar trials in Baltimore, MD

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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