NCT04650633Unknown2 期
A Phase II,Open-label Trial to Investigate the Efficacy and Safety of SHR-1701 in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) per RECIST 1.1
研究概览
简要总结
This is an open label, single-arm, multi-center, phase II study of SHR-1701 in patients with recurrent/metastatic SCCHN
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
- •Histologically confirmed Recurrent/Metastatic SCCHN,not include NPC
- •Subjects failure after 1 lines of platinum based chemotherapy or failure from anti-PD-1/PD-L1 antibody therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
- •Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Adequate hematological, hepatic and renal function as defined in the protocol Other protocol-defined inclusion criteria could apply.
排除标准
- •Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
- •Anticancer treatment within 28 days before the first dose of study drug.
- •Major surgery within 28 days before start of trial treatment.
- •Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
- •With any active autoimmune disease or history of autoimmune disease.
- •History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
研究组 & 干预措施
SHR-1701
Experimental
R/M SCCHN subjects failure after 1 lines of platinum based chemotherapy or after anti PD-1/PD-L1 antibody therapy.
干预措施: SHR-1701 (Drug)
结局指标
主要结局
Objective Response Rate (ORR) per RECIST 1.1
时间窗: up to 2 years
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least 30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
次要结局
- OS(24 months)
- DOR(24 months)
- DCR(24 months)
- PFS(24 months)
- AEs(24 months)
研究者
研究点 (1)
Loading locations...
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