NCT05020925Unknown1 期
A Phase I/II, Open-label, Multi-center Trial to Investigate the Efficacy and Safety of SHR-1701 in Combination With Famitinib in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
This is an open label, multi-center, phase I/II study to evaluate the efficacy and safety of SHR-1701 in combination with famitinib in subjects with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
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
- •Histologically confirmed Recurrent/Metastatic Nasopharyngeal Carcinoma
- •Subjects failure after platinum-based chemotherapy and anti-PD-1/PD-L1 antibody therapy;
- •Able and willing to provide signed informed consent form, and able to comply with all procedures.
- •Life expectancy >= 12 weeks as judged by the Investigator.
- •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
- •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.
- •With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
- •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.
- •Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
研究组 & 干预措施
SHR-1701 plus Famitinib
Experimental
SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy
干预措施: SHR-1701 (Drug)
SHR-1701 plus Famitinib
Experimental
SHR-1701+Famitinib for R/M NPC failure after platinum-based chemotherapy and anti PD-1/PD-L1 antibody therapy
干预措施: Famitinib (Drug)
结局指标
主要结局
ORR
时间窗: up to approximately 2 years (anticipated)
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
- DoR(up to approximately 2 years (anticipated))
- DCR(up to approximately 2 years (anticipated))
- PFS(up to approximately 2 years (anticipated))
- OS(up to approximately 2 years (anticipated))
- AEs(up to approximately 2 years (anticipated))
研究者
研究点 (1)
Loading locations...
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