NCT04421352已完成1 期
A Phase Ia/Ib, Open-Label, Multiple-Dose, Dose-Escalation and Expansion Study of the 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
- 11
- 试验地点
- 1
- 主要终点
- To determine the recommended radiation dose and preliminarily evaluate the anti-tumor efficacy of CS1001 in combination with low-dose radiotherapy in subjects with limited or extensive stage SCLC who failed the firstline treatment
研究概览
简要总结
A Phase Ia/Ib Safety and Tolerability Evaluation of Low-dose Radiation in Combination with CS1001 in relapsed SCLC patients
详细描述
This is a dose-escalation study of Low-dose Radiation in combination with CS1001 in relapsed SCLC patients. Patients are assigned to 3 treatment groups received from 3 Gy to 15Gy, to determine the safety, tolerability and the maximal tolerant dose. Biomarkers and immunological markers are collected and analyzed as well.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed LS-SCLC or ES-SCLC and experienced progression since first-line standard platinum containing dual-drug chemotherapy.
- •Patients whose initial diagnosis was limited must undergo radical chest radiotherapy and the time of tumor progression is not less than 3 months from the end of radiotherapy, or cannot receive radical chest radiotherapy due to specific reasons
- •At least one extracranial measurable lesion (RECIST v1.1), and for a lesion that has received radiotherapy, progression of the lesion after radiotherapy must be confirmed.
- •Patients with brain metastases are allowed to receive previous radiotherapy and their condition is stable, but the time to the end of radiotherapy must not be less than 3 months.
- •No radiotherapy contraindications were judged by the radiologist
- •ECOG performance status of 0 or
- •Patients with life expectancy ≥ 3 months.
- •Patients 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 6 months after last study drug administration.
排除标准
- •Subjects known to have primary CNS tumors or meningeal metastases or unstable CNS metastases.
- •Patients with active autoimmune diseases or history of autoimmune diseases should be excluded.
- •Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- •Known history of HIV infection.
- •Subjects with active chronic hepatitis B or active hepatitis C .
- •Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
- •Known history of alcoholism or drugs abuse.
- •Subjects with history of radiation pneumonitis of grade 3 or above, regardless of recovered or not.
研究组 & 干预措施
low-dose radiation+CS1001
Experimental
low-dose radiation+CS1001
干预措施: CS1001 (Drug)
结局指标
主要结局
To determine the recommended radiation dose and preliminarily evaluate the anti-tumor efficacy of CS1001 in combination with low-dose radiotherapy in subjects with limited or extensive stage SCLC who failed the firstline treatment
时间窗: From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years.
次要结局
- The number and percentage of subjects with detectable Anti-drug Antibody (ADA)(From first dose to 30 days after last dose of CS1001, up to 2 years.)
- Incidence of Adverse Events (AE) and Dose-Limiting Toxicity (DLT) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) V4.03(From first dose to 30 days after last dose of CS1001, up to 2 years.)
- Cmax: Peak concentration, the maximum drug concentration measured during one dosing cycle(From first dose to 30 days after last dose of CS1001, up to 2 years.)
研究者
研究点 (1)
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