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Recruiting Phase 1

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

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About this study

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

Condition
Castration-resistant Prostate Cancer
Tested
Investigational Agent Administration
Sponsor
Virginia Commonwealth University

Who can join

Age
18 years and older
Sex
Male only
Healthy volunteers
Not accepted

Inclusion 18

  • Minimum age: 18 years
  • Eligible sex: Male
  • Study condition: Castration-resistant Prostate Cancer
  • 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 20

  • 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

1 site, 1 recruiting

Virginia Commonwealth University

Richmond, Virginia, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.