A Phase 1, Open-Label, Multi-Center, Non-Randomized, Dose Escalation/Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SHR-1701 in Subjects With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Vital signs
研究概览
简要总结
This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-1701 in subjects with advanced solid tumors.
详细描述
This is a two-part, open-label, multicenter, non-randomized, dose escalation, Phase 1 study of repeated doses of SHR-1701 in subjects with advanced solid tumors who have failed current standard anti-tumor therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Diagnosed (histologically or cytologically) with solid tumors
- •ECOG Performance Status of 0 or 1 at both the screening and baseline visits
- •Life expectancy ≥12 weeks
- •Adequate laboratory parameters
- •Willing and able to comply with clinic visits and study-related procedures
- •Provide signed informed consent
排除标准
- •Known history of hypersensitivity to the study drug
- •Prior malignancy active within the previous 2 years
- •Any investigational or concurrent cancer therapy
- •History of immunodeficiency including seropositivity
- •Systemic antibiotics treatment for ≥ 7 days before the first dose
- •A known history of allogeneic organ transplantation
研究组 & 干预措施
Dose level 1
Subjects will receive a single dose of SHR-1701 at Dose level 1 on Day 1 of each cycle
干预措施: SHR-1701 (Drug)
Dose level 2
Subjects will receive a single dose of SHR-1701 at Dose level 2 on Day 1 of each cycle
干预措施: SHR-1701 (Drug)
Dose level 3
Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 of each cycle
干预措施: SHR-1701 (Drug)
Dose level 4
Subjects will receive a single dose of SHR-1701 at Dose level 2 1 on Day 1 and Day 15 of each cycle
干预措施: SHR-1701 (Drug)
Dose level 5
Subjects will receive a single dose of SHR-1701 at Dose level 3 on Day 1 and Day 15 of each cycle
干预措施: SHR-1701 (Drug)
Dose expansion 1
Subjects will receive a single dose of SHR-1701 on a selected dose level Day 1 of each cycle
干预措施: SHR-1701 (Drug)
Dose expansion 2
Subjects will receive a single dose of SHR-1701 on a selected dose level on Day 1 of each cycle
干预措施: SHR-1701 (Drug)
结局指标
主要结局
Vital signs
时间窗: Screening up to study completion, an average of 1 year
Incidence of vital sign abnormalities
Adverse events
时间窗: Screening up to study completion, an average of 1 year
Number of subjects with adverse events (AEs)
Laboratory results
时间窗: Screening up to study completion, an average of 1 year
Number of subjects with laboratory tests findings of potential clinical importance
Electrocardiogram
时间窗: Screening up to study completion, an average of 1 year
Number of subjects with clinically significant abnormal ECG QT Interval
次要结局
- Pharmacokinetic - Cmax(Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15)
- Pharmacokinetic - AUC∞(Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15)
- Pharmacokinetic - t1/2(Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15)
- Pharmacokinetic - Tmax(Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15)
- Pharmacokinetic - CL/F(Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15)
- Pharmacokinetic - Vz/F(Pre-dose, 10min(±2min), 1h(±5min), 2h(±5min), 6h(±10min) Post-dose on Cycle1 Day 1, pre-dose on Day 2, 3, 4, 8, 15)
- Pharmacodynamics- ADA(Pre-dose on Day1 of cycle 2,3,4,5,7,9,13,17)