NCT03744403已完成1 期
A Phase I, Open-Label, Multiple-Dose, Dose-Escalation Study of an Anti-PD-L1 Monoclonal Antibody CS1001 in Subjects With Advanced Solid Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in subjects with advanced solid tumors.
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
- •Subjects with metastatic or locally advanced unresectable solid tumor, who progressed following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
- •ECOG performance status of 0 or
- •Subjects must have at least one measurable lesion.
- •Patients with life expectancy ≥ 3 months.
- •Subject must have adequate organ function.
- •Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last study drug administration.
排除标准
- •Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- •Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
- •Patients who have received prior therapies targeting PD-1, PD-L1, or CTLA-
- •Known history of HIV infection.
- •Subjects with active Hepatitis B or C infection.
- •Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
- •Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
- •Known history of alcoholism or drugs abuse.
- •Subjects who received organ transplantation.
- •Known psychiatric disorders that would interfere with cooperation with the requirements of the trial.
- •Female subjects who are pregnant or breast-feeding; Male or female subjects of childbearing potential who refuse to use an effective method of birth control.
- •For more information regarding trial participation, please contact at cstonera@cstonepharma.com
研究组 & 干预措施
CS1001 monoclonal antibody
Experimental
干预措施: CS1001 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: From first dose to 90 days after last dose of CS1001, up to 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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