NCT03809767已完成1 期
A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the Anti-PD-1 Monoclonal Antibody CS1003 in Subjects With Advanced Solid Tumors or Lymphomas
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
- 107
- 试验地点
- 17
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is a phase Ia/Ib, open-label, multiple-dose, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1003 in subjects with advanced solid tumors or lymphoma.
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
- •Willing to sign the informed consent.
- •Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor or unresectable lymphoma and have progressed, are intolerant to, refuse to accept or do not have access to standard therapy.
- •ECOG performance status of 0 or
- •Subjects with evaluable but non-measurable lesion are eligible for Phase Ia. Subjects must have at least one measurable lesion per RECIST Version 1.1 to be eligible for Phase Ib.
- •Archived tumor tissue samples need to be collected, or subjects consent to undergo pre-treatment biopsy if archived sample is not available.
- •Life expectancy ≥ 3 months.
- •Subject must have adequate organ function.
- •Use of effective contraception (males and females).
排除标准
- •Subjects with known symptomatic or untreated brain metastasis or other CNS metastasis.
- •Subjects with active autoimmune diseases or history of autoimmune diseases.
- •Subjects who have to receive glucocorticoids (prednisone at > 10 mg/day or equivalent) or other immunosuppression within 14 days prior to the first dose of CS
- •Subjects with other malignant tumor(s) in the past 2 years are not eligible for Phase Ib
- •Subjects who have received any immune checkpoint treatment, including PD-1, PD-L1, etc.
- •History of HIV infection.
- •Subjects with active Hepatitis B and C infection requiring therapy.
- •Subjects with active infection of tuberculosis.
- •History of organ transplantation.
- •Unresolved toxicities from prior anti-cancer therapy.
- •History of uncontrolled allergic asthma and serious hypersensitive reaction to monoclonal antibodies.
- •Subjects with major cardiovascular diseases.
- •History of alcoholism or drugs abuse.
- •Any condition that, in the opinion of the investigator or sponsor, would jeopardize compliance.
研究组 & 干预措施
CS1003 monoclonal antibody
Experimental
干预措施: CS1003 monoclonal antibody (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: from the day of first dose to 90 days after last dose of CS1003
次要结局
未报告次要终点
研究者
研究点 (17)
Loading locations...
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