NCT06636123 GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy
| NCT ID | NCT06636123 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Virginia Commonwealth University |
| Condition | Castration-resistant Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-02-18 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-02-18 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
Eligibility Criteria
Inclusion Criteria: * Patients diagnosed with prostate cancer and treated with androgen deprivation therapy (ADT) and at least one androgen receptor pathway inhibitor (ARPI) (eg, abiraterone, enzalutamide, apalutamide or darolutamide). Previous prostate-specific membrane antigen (PSMA)-targeted therapy or cytotoxic chemotherapy is allowed but not required. * Androgen levels ≤50 ng/dL (≤1.73 nmol/L). * Disease progression following ADT and ARPI treatment described * PSA progression over 2 assessments, defined as rising PSA values from 2 consecutive assessments with an interval of at least 7 days between assessments. PSA levels prior to study enrollment are considered and appropriate for inclusion. * Measurable disease by RECIST v1.1 on chest/abdomen/pelvis CT or evaluable disease observed on bone scan. * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Appropriate hepatic function defined by a total bilirubin (TBL) ≤1.5 × the upper limit of normal (ULN), alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) ≤3 × ULN at screening. * Appropriate kidney function defined by calculated or actual creatinine clearance ≥30 mL/min * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3. * Platelets ≥100,000 cells/mm3. * Serum hemoglobin level ≥8 g/dL. * Agree to not donate blood or sperm during the study and for 90 days after the last dose of study treatment. * Patients with sexual partners of childbearing potential must agree to use highly effective methods of contraception throughout the study * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Any investigational agent: within 4 weeks OR within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before initiating study treatment. * Low PSA (≤10 ng/mL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases. * Simultaneous enrollment in any other cancer treatment interventional clinical trial. * Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not controlled with oral repletion. * Grade ≥3 uncontrolled infection. * Major surgery (in the opinion of the treating investigator) ≤3 weeks before initiating study treatment. * Not having fully recovered to a grade of 1 or lower from any surgery-related adverse effects within the 3 weeks preceding the start of the study treatment. * Small cell, anaplastic, or neuroendocrine component. * Known active brain metastasis. * Known active leptomeningeal disease. * Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment must be discontinued ≥2 weeks prior to initiating study treatment unless otherwise noted: * Monoamine oxidase inhibitors (MAOI) use; must discontinue use 10 days prior to initiating study therapy. * Strong or moderate CYP1A2, CYP3A4 and CYP2C19 inhibitors. * Rucaparib, Olaparib and Talazoparib, due to their common findings of liver enzyme elevation. * Inability to swallow medication. * Known hypersensitivity to GZ17-6.02 components (curcumin, harmine, and isovanillin) or excipients. * Known or suspected malabsorption condition or obstruction. * Active untreated hepatitis B or C" and "Known liver cirrhosis of any cause, active nonalcoholic steatohepatitis, or nonalcoholic fatty liver disease. Note: no additional testing necessary to confirm * Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Contact & Investigator
John Melson, MD
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT06636123 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Castration-resistant Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06636123 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06636123 currently recruiting?
Yes, NCT06636123 is actively recruiting participants. Contact the research team at masseyepd@vcu.edu for enrollment information.
Where is the NCT06636123 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT06636123 clinical trial?
NCT06636123 is sponsored by Virginia Commonwealth University. The principal investigator is John Melson, MD at Virginia Commonwealth University. The trial plans to enroll 30 participants.
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