A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection in Combination With SHR-1316 in Patients With Advanced Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 4
- 主要终点
- Adverse events
研究概览
简要总结
This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose escalation:SHR-2002+SHR-1316
SHR-2002 +SHR-1316 C1D1 SHR-2002,C1D22 SHR-2002+SHR-1316, C2 SHR-2002+SHR-1316
干预措施: SHR-2002 and SHR-1316 (Drug)
Dose expansion stage: SHR-2002+SHR-1316
Dose expansion of SHR-2002 will be decided after finishing few cohorts in Dose escalation part.
干预措施: SHR-2002 and SHR-1316 (Drug)
Indication expansion stage：SHR-2002+SHR-1316
Indication expansion of SHR-2002 will be decided after finishing few cohorts in Dose expansion part.
干预措施: SHR-2002 and SHR-1316 (Drug)
结局指标
主要结局
Adverse events
时间窗: Screening up to study completion, an average of 2 years
Number of subjects with adverse events (AEs)
Number of participants experiencing Dose-Limiting Toxicities (DLTs)
时间窗: Up to 42 days
According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
次要结局
- PK of SHR-2002 + SHR-1316(Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years)
- Immunogenicity of SHR-2002 + SHR-1316(Before and after SHR-2002 and SHR-1316 infusion throughout the study, an average of 2 years)