gz17-6.02 in advanced crpc after progression on anti-androgen therapy

Conditions: Castration-resistant Prostate Cancer

Summary: the purpose of this clinical trial is to determine if gz17-6.02 delays progression of castration-resistant prostate cancer.

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.

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