A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a multicenter, open-label phase I/II study, divided into 2 parts:
Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2.
Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
Dose Escalation
A total of six dose escalations were preset: 0.1 mg, 0.3 mg, 1 mg, 3 mg.
干预措施: ZG006 (Biological)
Dose Expansion
Participants will receive the RP2D identified in Dose Escalation Study .
干预措施: ZG006 (Biological)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Up to approximately 2 years
ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.
次要结局
- Number of participants with adverse events (AEs)(Up to approximately 2 years)