A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
试验速览
- 阶段
- 1 期
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies
详细描述
This is an open-label, non-randomized, dose escalation/expansion phase I study, SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
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
- •Male or female ≥18 years of age
- •Subjects with confirmed advanced malignancies (histologically or cytologically)
- •ECOG Performance status of 0 or 1
- •Adequate organ functions
- •Life expectancy ≥12 weeks;
排除标准
- •Subjects with active autoimmune disease.
- •Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment
- •Previous received PD-1 or PD-L1 therapy
- •Known Active central nervous system (CNS) metastases
- •Known Clinically significant cardiovascular condition
- •Active infection or an unexplained fever >38.5°C
- •History of immunodeficiency
研究组 & 干预措施
Escalation
SHR-1316 administrated intravenously(IV) at protocol defined dose levels
干预措施: SHR-1316 (Drug)
Expansion
SHR-1316 administrated IV in advanced solid tumors and selected tumor type
干预措施: SHR-1316 (Drug)
结局指标
主要结局
Adverse Events
时间窗: at the end of cycle one(each cycle is 21 days)
incidence and severity of treatment-related adverse events
Dose-limiting toxicities (DLTs)
时间窗: at the end of cycle one(each cycle is 21 days)
Number of participants with DLTs
次要结局
未报告次要终点