GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy

Trial Title: GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy

NCT ID: NCT06636123

Condition: Castration-resistant Prostate Cancer

Conditions: Official terms:
Prostatic Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Investigational Agent Administration
Description: GZ17-6.02 will be taken orally with a high-fat meal at a fixed dose of 375 mg twice daily each day of a 28-day cycle, continuing until progression or intolerable toxicity
Arm group label: Investigational Agent Administration

Summary: The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.

Detailed description: This single-arm phase Ib study will assess whether GZ17-6.02, a combination of curcumin, harmine, and isovanillin, delays radiographic progression of castration-resistant prostate cancer among men previously treated with androgen deprivation therapy and an androgen receptor pathway inhibitor. All participants in the study will receive GZ17-6.02. The study will also assess the safety and tolerability of GZ17-6.02 and explore patient-reported outcomes.

Criteria for 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 ≥9 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

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Virginia Commonwealth University

Address:
City: Richmond
Zip: 23298
Country: United States

Contact:
Last name: Massey Investigator-Initiated Trials Research Operations

Phone: 804-628-5006
Email: masseyepd@vcu.edu

Contact backup:
Last name: Massey CTO GU Team
Email: masseygu@vcu.edu

Investigator:
Last name: John Melson, MD
Email: Principal Investigator

Start date: November 13, 2024

Completion date: September 30, 2031

Lead sponsor:
Agency: Virginia Commonwealth University
Agency class: Other

Source: Virginia Commonwealth University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06636123