A Phase Ib/II Study of the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Combination With ZG005 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma(NEC)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
研究概览
简要总结
This study is a randomized, multicenter, Phase Ib/II clinical trial, aimed at evaluating the efficacy and safety of the combination of ZG006 and ZG005 in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 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 18-70 years of age.
- •Participants with advanced small cell lung cancer or neuroendocrine carcinoma confirmed by histopathology or cytology.
- •Eastern Cooperative Oncology Group (ECOG) 0 to
- •Life expectancy > 3 months.
排除标准
- •The investigator believes that the subject has other reasons that make them unsuitable for participation in this study.
研究组 & 干预措施
Phase II
Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.
干预措施: ZG006 (Drug)
Phase Ib: Part1-Dose Escalation
This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.
干预措施: ZG006 (Drug)
Phase Ib: Part1-Dose Escalation
This study will employ the traditional "3+3" dose escalation design. Ultimately, two combination dosing cohorts will be selected to enter Part 2, the dose expansion phase, based on a comprehensive evaluation of the safety and pharmacokinetic (PK) data obtained by the investigators and the sponsor.
干预措施: ZG005 (Drug)
Phase Ib: Part2-Dose Expansion
The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
干预措施: ZG006 (Drug)
Phase Ib: Part2-Dose Expansion
The safety and pharmacokinetic (PK) data obtained in Part 1 will be used to determine two expansion phase doses of the ZG006 and ZG005 combination. The dose expansion study will further evaluate the efficacy of the two selected combination dosing cohorts in patients with advanced small cell lung cancer and neuroendocrine carcinoma.
干预措施: ZG005 (Drug)
Phase II
Participants will receive the RP2D of ZG006 in combination with ZG005 identified in Phase Ib of the study.
干预措施: ZG005 (Drug)
结局指标
主要结局
Number of Participants Who Experienced Dose-limiting Toxicity (DLT)
时间窗: up to 28 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 2 years
Objective Response Rate (ORR)
时间窗: Up to 2 years
The objective response rate was defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR) based on the modified RECIST v1.1.
次要结局
- Progression-free Survival (PFS)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Disease Control Rate (DCR)(Up to 2 years)