A Phase I/II Dose Escalation Study to Evaluating the Tolerability, Safety, Efficacy and Pharmacokinetics of ZG2001 Tosilate Tablets in Participants With KRAS Mutated Advanced Solid Tumours
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
This study will evaluate the tolerability, safety, effects, and pharmacokinetics of ZG2001 in Participants with advanced solid tumors that have a KRAS mutation.
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
- •Participants who fully understood this study and voluntarily signed the informed consent form;
- •Men or women ≥ 18 years old;
- •Participants with a KRAS mutant solid tumor should have progressed on or are ineligible for all therapy(ies) known to confer clinical benefit.
- •ECOG Performance Status (PS) 0 or 1;
- •Life expectancy > 3 months.
排除标准
- •Received any SOS1 inhibitors;
- •Participants with a known history of hypersensitivity reactions to the ingredients of the preparations used in this study;
- •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
This Phase adopts an open-label design, with an Accelerated Titration(AT) design for the low-dose group (50 mg Bid) and the standard "3+3" design for the high-dose groups（100 mg Bid、50 mg Qd、100 mg Qd、200 mg Qd）.
干预措施: ZG2001 Tosilate Tablets (Drug)
Phase 2 Dose Expansion
After the completion of the dose escalation study, RP2D will be selected for dose expansion in advanced solid tumors (such as non-small cell lung cancer, colorectal cancer, pancreatic cancer, etc.) with KRAS mutations that have failed at least the first-line standard treatment
干预措施: ZG2001 Tosilate Tablets (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: Up to 21 Days
A DLT is defined as any Grade ≥ 3 AE meeting the criteria listed below occurring during the 1st treatment cycle of ZG2001 (Day 1 through Day 21) where the relationship to ZG2001 cannot be ruled out.
Incidence of Treatment-Emergent Adverse Events
时间窗: Up to 24 Months
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v5.0
次要结局
未报告次要终点