Actively Recruiting
The COSMYC Trial (COmbined Suppression of MYC)
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-09-17
50
Participants Needed
1
Research Sites
314 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
Z
Zenith Epigenetics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The COSMYC Trial (COmbined Suppression of MYC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance status 2 or less
- Age 18 years or older
- Histologically confirmed prostate adenocarcinoma
- Undergoing continuous androgen ablative therapy (surgical castration or LHRH agonist/antagonist)
- Documented castrate serum testosterone level (<50 ng/dl)
- Metastatic disease confirmed by CT, bone scan, or PSMA scan
- Disease progression on second-generation AR-axis inhibitor therapy
- Screening PSA level 1.0 ng/mL or higher
- Agreement to biopsy if soft tissue lesions are present
- Prior treatments such as Provenge, 223 Radium, PARP inhibitors, taxane chemotherapy, Pluvicto, antiandrogens, and radiation allowed if over 4 weeks since last dose
- Prior Bipolar Androgen Therapy allowed if progressed after AR-axis inhibitor
- Discontinued second-generation AR-axis inhibitors for 2 weeks or more
- Efforts to wean off prednisone before starting therapy; low dose allowed if needed
- Liver function within acceptable limits (bilirubin and liver enzymes below 2.5 times upper limit)
- Renal function within acceptable limits (serum creatinine below 2.5 times upper limit)
- Hematologic status within acceptable limits (neutrophils, platelets, hemoglobin)
- Ability to understand and sign informed consent
- Agreement to contraception methods if sexually active with female partners of childbearing potential
- Agreement to abstinence or condom use if partner is pregnant or breastfeeding
- Agreement to serial biopsies if soft tissue disease is present and biopsy is feasible
You will not qualify if you...
- Pain from metastatic prostate cancer requiring opioid treatment
- ECOG Performance status 3 or higher
- Need for urinary self-catheterization due to prostate cancer or benign prostatic hyperplasia
- Active uncontrolled infection
- History of HIV/AIDS unless stable with adequate CD4 counts and viral load
- Chronic hepatitis B or C infection not well controlled
- Conditions impairing informed consent or safety
- Current use of warfarin, rivaroxaban, or apixaban anticoagulants
- Recent thromboembolic event within past 12 months without anticoagulation
- Hematocrit over 51%, untreated severe sleep apnea, uncontrolled heart failure
- Allergy to sesame seed oil or cottonseed oil
- Major surgery within 3 weeks before screening or incomplete recovery
- History of seizures or conditions increasing seizure risk
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
S
Samuel Denmeade, MD
CONTACT
S
Sin Chan, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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