A Phase Ib, Open-label Trial to Investigate the Safety and Tolerability of SHR-1701 in Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma
试验速览
- 阶段
- 1 期
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Toxicity Toxicity
研究概览
简要总结
This is an open label, phase Ib Study of SHR-1701 in patients with recurrent/metastatic nasopharyngeal carcinoma(R/M NPC).
详细描述
The main purpose of this study is to assess the safety and tolerability of SHR-1701 in patients with R/M NPC. The secondary purpose is to assess the anti-tumor activity and immunogenicity of SHR-1701 in R/M NPC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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; failure from anti-PD-1/PD-L1 antibody therapy; Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment; failure from first line anti-PD-1/PD-L1 antibody therapy.
- •Able and willing to provide signed informed consent form, and able to comply with all procedures.
- •Histologically or cytologically proven metastatic or locally advanced solid tumors.
- •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
- •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.
- •With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
- •Clinically significant cardiovascular and cerebrovascular diseases
- •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.
- •Receipt of any organ transplantation, including allogeneic stem-cell transplantation Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
SHR-1701 plus Albumin Paclitaxel (Arm D)
SHR-1701+Albumin Paclitaxel for R/M NPC failure after first line anti PD-1/PD-L1 antibody therapy
干预措施: SHR-1701 (Drug)
SHR-1701 (Arm A)
SHR-1701 for R/M NPC failure after platinum-based chemotherapy
干预措施: SHR-1701 (Drug)
SHR-1701 (Arm B)
SHR-1701 for R/M NPC failure after anti PD-1/PD-L1 antibody therapy
干预措施: SHR-1701 (Drug)
SHR-1701 plus Gemcitabine and Cisplatin (Arm C)
SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC
干预措施: SHR-1701 (Drug)
SHR-1701 plus Gemcitabine and Cisplatin (Arm C)
SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC
干预措施: Gemcitabine (Drug)
SHR-1701 plus Gemcitabine and Cisplatin (Arm C)
SHR-1701+Gemcitabine+Cisplatin for first line treatment of R/M NPC
干预措施: Cisplatin (Drug)
SHR-1701 plus Albumin Paclitaxel (Arm D)
SHR-1701+Albumin Paclitaxel for R/M NPC failure after first line anti PD-1/PD-L1 antibody therapy
干预措施: Albumin Paclitaxel (Drug)
结局指标
主要结局
Toxicity Toxicity
时间窗: up to 2 years
Number of participants with adverse events as assessed by CTCAE v5.0
次要结局
- Objective Response Rate (ORR) per RECIST 1.1(up to 2 years)
- Immunogenicity of SHR-1701(up to 2 years)
- Overall Survival (OS)(up to 2 years)
- Progression-free Survival (PFS) per RECIST 1.1(up to 2 years)
- Disease Control Rate (DCR) per RECIST 1.1(up to 2 years)