NCT07231445招募中1 期
A Phase Ib Study Evaluating the Safety and Efficacy of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a randomized, multicenter, phase Ib study to evaluate the safety and efficacy of ZG006 combined with PD-1/PD-L1 immune checkpoint inhibitors (±chemotherapy) as first-line therapy in Participants with extensive stage small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with histologically or cytologically confirmed ES-SCLC.
- •Fully understand the study and voluntarily sign the informed consent form;
- •Male or female 18~75 years of age;
- •Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
- •Life expectancy ≥ 3 months;
排除标准
- •Participants were deemed unsuitable for participating in the study by the investigator for any reason.
研究组 & 干预措施
Part 1：Group A
Experimental
ZG006 Q3W
干预措施: ZG006 (Drug)
Part 1：Group A
Experimental
ZG006 Q3W
干预措施: Serplulimab (Drug)
Part 1：Group B
Experimental
ZG006 Q3W
干预措施: ZG006 (Drug)
Part 1：Group B
Experimental
ZG006 Q3W
干预措施: Serplulimab (Drug)
结局指标
主要结局
Number of Participants Experiencing Dose-limiting toxicities (DLTs)
时间窗: Up to Day 28
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 2 Years
次要结局
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1(Up to 2 Years)
- Maximum Serum Concentration (Cmax) of ZG006(Up to 2 Years)
- Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for ZG006(Up to 2 Years)
研究者
研究点 (1)
Loading locations...
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