NCT07024277尚未招募2 期
A Phase II Study Evaluating the Preliminary Efficacy and Safety of ZG006 in Participants With Metastatic Neuroendocrine Prostate Cancer
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Modified Best Overall Response（mBOR）
研究概览
简要总结
This is a multicenter, open-label Phase II study, aimed at exploring the preliminary efficacy and safety of ZG006 in patients with advanced metastatic NEPC who have previously failed standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Participants aged 18 to 80 years (inclusive);
- •Advanced metastatic neuroendocrine prostate cancer;
- •disease progression after at least one line of platinum-based systemic therapy or intolerance to toxicity;
- •Measurable disease according to RECIST v1.1 criteria;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
排除标准
- •Known positive test for human immunodeficiency virus (HIV) or hepatitis；
- •Patients were deemed unsuitable for participating in the study by the investigator for any reason.
研究组 & 干预措施
Part2
Experimental
Participants will receive the RP2D identified in Part 1 of the study.
干预措施: ZG006 (Biological)
Part 1
Experimental
The preliminary efficacy and safety of ZG006 at the two determined potential Phase II recommended doses (10 mg and 30 mg) will be assessed in Participants with advanced metastatic NEPC.
干预措施: ZG006 (Biological)
结局指标
主要结局
Modified Best Overall Response（mBOR）
时间窗: Baseline to 12 months
mBOR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with Prostate Cancer Working Group 3 (PCWG3) modifications.
次要结局
- Duration of Response (DOR)(Baseline to 12 months)
- Overall Survival (OS)(Baseline to 12 months)
- Disease Control Rate (DCR)(Baseline to 12 months)
- Adverse Events（AE）(Day 1 to 12 months)
研究者
研究点 (1)
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