NCT07830199尚未招募1 期
An Open-label, Multicenter Phase I Clinical Study of SHR-4595 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability and Pharmacokinetics
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Adverse events (AEs)
研究概览
简要总结
The study is being conducted to evaluate the safety and tolerability of SHR-4595 for injection in participants with advanced solid tumors, and to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended dose for Phase II clinical studies (RP2D) of SHR-4595.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject must satisfy all of the following criteria to be considered for inclusion in the study.
- •The subjects voluntarily joined the study and signed the ICF.
- •Measurable disease, as defined by RECIST v1.
- •The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or
- •Life expectancy ≥ 12 weeks.
- •Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.
排除标准
- •A subject who meets any of the following criteria will be excluded from study entry.
- •Symptomatic, untreated or active central nervous system metastases.
- •Have uncontrolled or severe cardiovascular disease Have clinical symptoms or disease of the heart that are not well controlled.
- •With any active autoimmune disease or history of autoimmune disease.
- •Patients with active hepatitis B or hepatitis C.
- •Severe infections prior to initiation of study treatment.
研究组 & 干预措施
SHR-4595 Group
Experimental
SHR-4595 for Injection, in different stages with different doses.
干预措施: SHR-4595 for Injection (Drug)
结局指标
主要结局
Adverse events (AEs)
时间窗: From Day 1 to 40 days after last dose.
Safety endpoints.
Dose-limiting toxicity (DLT)
时间窗: From Day 1 to 12 months.
Safety endpoints.
Maximum Tolerated Dose (MTD)
时间窗: From Day 1 to 12 months.
Safety endpoints.
Recommended Phase 2 Dose (RP2D)
时间窗: From Day 1 to 12 months.
Safety endpoints.
次要结局
- Progression free survival (PFS)(From Day 1 to 12 months.)
- Objective response rate (ORR)(From Day 1 to 12 months.)
- Disease control rate (DCR)(From Day 1 to 12 months.)
- Duration of response (DOR)(From Day 1 to 12 months.)
- Overall survival (OS)(From Day 1 to 12 months.)
研究者
研究点 (2)
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