A Phase I/II Dose Escalation and Expansion Study to Evaluating the Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who fully understood this trial and voluntarily signed the informed consent form;
- •Men or women ≥ 18 years old;
- •ECOG Performance Status (PS) 0 or 1;
- •Life expectancy > 3 months.
排除标准
- •Received any treatment with inhibitors against KRAS G12C mutation at any time, e.g., AMG 510, MRTX 849, etc.;
- •Patients requiring medications that can potentially prolong QTc interval;
- •Other conditions that the investigator considers to be unsuitable for participation in this study.
研究组 & 干预措施
Phase 1 Dose Escalation
Dose escalation will begin with rapid dose escalation for the low-dose groups (50 mg QD 、150 mg QD) and a "3 + 3" dose-escalation protocol for the high-dose groups.
干预措施: ZG19018 (Drug)
Phase 2 Dose Expansion
Upon completing the dose escalation part of the study, dose expansion may proceed with 3 groups consisting of subjects with KRAS G12C mutant advanced solid tumors，Including non-small cell lung cancer, colorectal cancer and Other advanced solid tumors
干预措施: ZG19018 (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: Up to 21Days
A DLT is defined as any Grade ≥ 3 AE meeting the criteria listed below occurring during the first treatment cycle of ZG19018 (day 1 through day 21) where elationship to ZG19018 cannot be ruled out.
Objective Response Rate (ORR)
时间窗: Up to 24 Months
The sum of the proportions of subjects who achieved CR or PR in imaging evaluation as assessed by the investigator based on RECIST1.1 criteria.
次要结局
未报告次要终点