NCT03523819已完成1 期
A Phase Ia/Ib, Open-Label, Dose-Escalation, and Dose-Expansion Study of the Anti-CTLA-4 Monoclonal Antibody CS1002 as Monotherapy and in Combination With Anti-PD-1 Monoclonal Antibody CS1003 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
- 91
- 试验地点
- 10
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is a multicenter, open-label, multiple dose, dose escalation phase I study to evaluate the clinical safety, tolerability, PK, and preliminary anti-tumor efficacy of CS1002.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Randomized for Part 3 of the study
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 histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- •ECOG performance status of 0 or
- •Life expectancy ≥12 weeks.
- •Subjects must have adequate organ function
- •Use of effective contraception
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.
- •Subjects with immunodeficiency or receiving systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of CS
- •Has received prior therapy with an anti-CTLA-4 agent.
- •Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other anti cancer systemic treatment, within 14 days prior to the first dose of CS1002 or who has not recovered from adverse events due to prior therapy.
- •Receipt of major surgical procedure, wide field of radiation, local radiotherapy or radioactive agents within specified time frame prior to the first dose of CS
- •Receipt of live vaccine within 28 days prior to the first dose of CS1002
- •Use of traditional medicinal herbal preparations within 7 days prior to the first dose of CS
- •History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapies.
- •Known history of HIV.
- •Subjects with active Hepatitis B or C infection
- •Subjects with active tuberculosis infection.
- •Subjects with an active infection requiring systemic therapy.
- •History of organ transplantation.
- •History of alcoholism or drugs abuse.
- •History of severe hypersensitivity reactions to other mAbs.
- •Subjects with major cardiovascular diseases.
- •For more information regarding trial participation, please contact at cstonera@cstonepharma.com
研究组 & 干预措施
CS1002
Experimental
Participants will receive CS1002 intravenously at specified dose on specified days.
干预措施: CS1002 (Drug)
CS1002
Experimental
Participants will receive CS1002 intravenously at specified dose on specified days.
干预措施: CS1003 (Drug)
CS1003
Experimental
Participants will receive CS1003 intravenously at fixed dose on specified days.
干预措施: CS1002 (Drug)
CS1003
Experimental
Participants will receive CS1003 intravenously at fixed dose on specified days.
干预措施: CS1003 (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 30 days after last dose of CS1002
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
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