An Open-label, Multicenter Phase I/II Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- The Dose-Limiting Toxicity (DLT)
研究概览
简要总结
This study is an open, multicenter Phase I/II clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
- •Age range: 18-75 years old, both male and female are welcome;
- •Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;
- •Have at least one measurable tumor lesion per RECIST v1.1;
- •ECOG performance status of 0-1;
- •Life expectancy ≥ 12 weeks;
- •Adequate bone marrow and organ function.
排除标准
- •Patients with active central nervous system metastases or meningeal metastases;
- •Systemic antitumor therapy was received 4 weeks before the start of the study;
- •Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;
- •Have poorly controlled or severe cardiovascular disease;
- •Subjects with active hepatitis B or active hepatitis C;
- •Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.
研究组 & 干预措施
Cohort 7：SHR-4610 dose D +SHR-A1811 dose A in Satefy run in Stage
干预措施: SHR-4610 Injection (Drug)
Cohort 7：SHR-4610 dose D +SHR-A1811 dose A in Satefy run in Stage
干预措施: SHR-A1811 for injection (Drug)
Cohort 1 Group
SHR-4610 dose A in dose escalation stage.
干预措施: SHR-4610 Injection (Drug)
Cohort 2 Group
SHR-4610 dose B in dose escalation stage.
干预措施: SHR-4610 Injection (Drug)
Cohort 5 Group
SHR-4610 dose A/B/C/D in dose expansion stage.
干预措施: SHR-4610 Injection (Drug)
Cohort 3 Group
SHR-4610 dose C in dose escalation stage.
干预措施: SHR-4610 Injection (Drug)
Cohort 4 Group
SHR-4610 dose D in dose escalation stage.
干预措施: SHR-4610 Injection (Drug)
Cohort 6 Group
SHR-4610 dose A/B/C/D in efficacy expansion stage.
干预措施: SHR-4610 Injection (Drug)
Cohort 8：SHR-4610 dose D+SHR-A1811 dose A in Satefy run in Efficacy expansion stage
干预措施: SHR-4610 Injection (Drug)
Cohort 8：SHR-4610 dose D+SHR-A1811 dose A in Satefy run in Efficacy expansion stage
干预措施: SHR-A1811 for injection (Drug)
结局指标
主要结局
The Dose-Limiting Toxicity (DLT)
时间窗: Post-dose at day 1 to the end of treatment visit, about 1 year.
The Maximum Tolerated Dose (MTD)
时间窗: Post-dose at day 1 to the end of treatment visit, about 1 year.
Incidence and severity of adverse events (AEs)
时间窗: Up to 90 days after the last administration.
Recommended dosage for Phase II (RP2D)
时间窗: Post-dose at day 1 to the end of treatment visit, about 1 year.
次要结局
- Objective Response Rate (ORR)(From the first administration to the end of treatment visit, about 1 year.)
- Time to the maximum plasma concentration (Tmax)(From Day 1 pre-dose to 30 days after the last administration.)
- Disease Control Rate (DCR)(From the first administration to the end of treatment visit, about 1 year.)
- Maximum concentration of SHR-4610 (Cmax)(From Day 1 pre-dose to 30 days after the last administration.)
- Duration of relief (DOR)(From the first administration to the end of treatment visit, about 1 year.)
- Time to Response (TTR)(From the first administration to the end of treatment visit, about 1 year.)
- SHR-4610 serum trough concentration (Ctrough)(From Day 1 pre-dose to 30 days after the last administration.)
- Progression-free survival (PFS)(From the first administration to the end of treatment visit, about 1 year.)
- Area under the concentration versus time curve of SHR-4610 from time zero to time t (AUC0-t)(From Day 1 pre-dose to 30 days after the last administration.)