A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicities (DLTs)
研究概览
简要总结
The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists
- •ECOG Performance Status ≤ 2
排除标准
- •Active autoimmune disease
- •Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- •Prior PD-1- or PD-L1-directed therapy
- •Other protocol defined inclusion/exclusion may apply.
研究组 & 干预措施
PDR001
PDR001 will be administered i.v. every two weeks until a patient experiences unacceptable toxicity, progressive disease as per irRC and/or treatment is discontinued at the discretion of the investigator or the patient. The treatment period will begin on Cycle 1 Day 1. For the purpose of scheduling and evaluations, a treatment cycle will consist of 28 days. During the study, cohorts of patients will be treated with PDR001 until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established.
干预措施: PDR001 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicities (DLTs)
时间窗: 28 days
cycle = 28 days
次要结局
- Duration of response rate (DOR)(up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks))
- PK parameter: Cmax(Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1))
- PK parameter: Tmax(Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1))
- PK parameter: AUC(Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1))
- Serum concentration vs. time profiles(C1D1, C3D1)
- Presence and/or concentration of anti-PDR001 antibodies(Day 1 on from C1 to C6)
- Objective response rate (ORR)(up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks))
- Disease control rate (DCR)(up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks))
- PK parameter: half-life(Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1))