NCT06636123招募中1 期
GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Radiologic progression-free survival (rPFS) for 6 months or longer
研究概览
简要总结
The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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/mm
- •Platelets ≥100,000 cells/mm
- •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
排除标准
- •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
研究组 & 干预措施
Investigational Agent Administration
Experimental
GZ17-6.02: 375mg twice daily
干预措施: Investigational Agent Administration (Drug)
结局指标
主要结局
Radiologic progression-free survival (rPFS) for 6 months or longer
时间窗: 6 months and up to 5 years after end of study treatment
Number of participants with rPFS for 6 months or longer
次要结局
- Measure the biochemical response rate of CRPC tumors to GZ17-6.02(Up to 5 years following end of study treatment)
- Measure the duration of response of CRPC tumors to GZ17-6.02(Up to 5 years following end of study treatment)
- Assess the objective response rate (ORR) in CRPC patients treated with twice daily GZ17-6.02.(Up to 5 years following end of study treatment)
- Measure the duration of radiographic response in CRPC patients treated with twice daily GZ17-6.02(Up to 5 years following end of study treatment)
- Measure overall survival (OS) in CRPC patients treated with twice daily GZ17-6.02(Up to 5 years following end of study treatment)
- Determine the safety and tolerability of twice daily treatment with GZ17-6.02(Beginning of study treatment through the 30-day follow-up safety assessment up to 5 years)
研究者
研究点 (1)
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