A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody (JS002) Combined With Toripalimab in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities (DLTs)
研究概览
简要总结
This open-label phase I clinical study with clinical development phase will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JS002 combined with Toripalimab in advanced cancer patients, who has failed standard therapy OR could not tolerate standard therapy OR refused/had no standard therapy.
This study is divided into two parts:
Part A. JS002 combined with Toripalimab dose escalation and dose expansion phase; Part B.JS002 combined with Toripalimab clinical expansion phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
JS001(Toripalimab)+JS002
干预措施: JS001(Toripalimab)+JS002 (Drug)
结局指标
主要结局
Dose-limiting toxicities (DLTs)
时间窗: 3 years
Safety endpoints
adverse events (AE)、SAE、irAE
时间窗: 3 years
Safety endpoints: adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE);
MTD
时间窗: 1 year
Maximum tolerated dose (MTD)
Recommended dose for extension (RDE)
时间窗: 1 year
Recommended dose for extension (RDE)
次要结局
- DCR(2 years)
- TTR(2 years)
- DOR(2 years)
- PFS(2 years)
- ORR(2 years)
- Peak concentration（Cmax）(2 years)
- Peak time（Tmax）(2 year)
- Elimination half-life (T1/2)(2 years)
- OS(2 years)
- 1-year OS rate(1 year)
- Pharmacokinetic (PK) characteristics(2 years)
- Clearance rate (CL)(2 years)
- Volume of distribution (Vss)(2 years)
- Area under blood concentration-time curve (AUC0-T and AUC0-)(2 years)
- ADA against(2 years)