NCT03316144已完成1 期
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Injection in Patients With Recurrent Malignant Lymphoma
Shanghai Junshi Bioscience Co., Ltd.1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年7月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
The primary objective is to assess the safety and tolerability of JS-001 in subjects with recurrent malignant lymphoma, and to evaluate its preliminary efficacy.
The secondary objectives are to: 1) characterize the single-dose and multi-dose pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3) assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate biomarkers associated with the efficacy of JS-001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to sign Informed Consent;
- •Re-entry into the study is allowed with a second informed consent;
- •Willing to provide blood sample for biomarker analysis(mandatory). The tissue sample is optional;
- •A diagnosis of an advanced malignant tumor confirmed by histology or cytology (including typical Hodgkin's lymphoma and B cell source non-hodgkin's lymphoma);
- •No standard of care for the patient;
- •At least 1 measurable lesion;
- •Aged 18-65 years;
- •Anticipated life expectancy of at least 6 months;
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- •At least 4 weeks elapsed since receiving systemic chemotherapy;
- •At least 4 weeks elapsed since receiving definite radiotherapy;
- •At least 2 weeks since the last dose of systemic steroid therapy (>10 mg/day prednisone or equivalent);
- •At least 4 weeks since receiving anti-cancer biotherapy;
- •Recovered from previous treatment related adverse reaction; willing to use an acceptable contraceptive method;
- •A negative pregnancy test for female subjects of childbearing potential;
排除标准
- •Active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- •Known history of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 2 years, or underwent successful definitive resection of basal or squamous cell carcinoma of the skin, or in situ cervical cancer;
- •Active, known or suspected autoimmune disease.Autoimmune diseases caused by lymphoma are not included in this list;
- •Patients who have had car-T cell therapy
- •Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) blocking antibodies;
- •Significant medical disease;
- •Active infection;
- •Active tuberculosis or history of tuberculosis with one year;
- •Infection of Human immunodeficiency virus (HIV);
- •A complication requiring immune-suppression;
- •Received a live vaccine within 4 weeks prior to first dose of study drug pleural or abdominal effusion with symptoms;
- •Drug or alcohol abuse (for subjects in the pharmacokinetic cohorts) ; evidence of interstitial lung disease;
- •Active hepatitis B or C, or with significant risk of hepatitis reactivation;
- •Known immediate or delayed hypersensitivity reaction or idiosyncrasy to monoclonal antibodies or drugs chemically related to the study drug. History of serious hypersensitivity reaction or serious hepatotoxicity related to any drug.
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: 6 months
次要结局
- correlation analysis of PD-L1 expression of tumor(6 months)
- Objective Response Rate (ORR) by irRC and RECIST 1.1(6 months)
研究者
研究点 (1)
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