NCT04611321终止1 期
A Phase Ib/II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of IBI318 in Participants With Advanced Cutaneous Squamous Cell Carcinoma.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.
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
- •Able to understand and willing to sign the ICF.
- •Adults 18 years of age or older.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Life expectancy at least 12 weeks.
- •Adequate organ and bone marrow function.
- •Histologically confirmed diagnosis of invasive CSCC. .
排除标准
- •Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- •Any investigational drugs received within 4 weeks prior to the first study treatment.
- •Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
- •History of autoimmune disease , present active autoimmune disease or inflammatory diseases
- •Pregnant or nursing females.
研究组 & 干预措施
Phase Ib/II
Experimental
Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks.
干预措施: IBI318 (Drug)
结局指标
主要结局
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
时间窗: 24 months
RECIST version 1.1 will be used to determine ORR by IRRC
次要结局
- Investigator Assessments of Overall Response Rate(24 months)
- Duration of response(24 months)
- PFS (progression-free survival)(24 months)
- Overall Survival(24 months)
- AEs and SAEs(30 months)
研究者
研究点 (1)
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