GZ17-6.02 treatment for advanced prostate cancer after hormone therapy

GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy

This study is testing a new treatment called GZ17-6.02 to see if it can help men with advanced prostate cancer that hasn't responded to hormone therapy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Virginia Commonwealth University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Richmond, Virginia)
• Trial ID: NCT06636123 on ClinicalTrials.gov

What this trial studies

This phase Ib clinical trial evaluates the effectiveness of GZ17-6.02, a combination of curcumin, harmine, and isovanillin, in delaying the progression of castration-resistant prostate cancer in men who have previously undergone androgen deprivation therapy and treatment with an androgen receptor pathway inhibitor. All participants will receive the investigational agent, and the study will also monitor safety, tolerability, and patient-reported outcomes. The trial aims to provide insights into the potential benefits of this novel treatment approach.

Who should consider this trial

Good fit: Ideal candidates include men diagnosed with castration-resistant prostate cancer who have previously been treated with androgen deprivation therapy and an androgen receptor pathway inhibitor.

Not a fit: Patients who have not received prior androgen deprivation therapy or androgen receptor pathway inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly delay disease progression in men with advanced prostate cancer.

How similar studies have performed: While this approach is novel, similar studies exploring the use of natural compounds in cancer treatment have shown promising results.

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

Where this trial is running

Richmond, Virginia

• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: John Melson, MD — Virginia Commonwealth University
• Study coordinator: Massey IIT Research Operations

Conditions Castration-resistant Prostate Cancer