Phase 1, Open Label Study to Assess the Safety and Pharmacokinetics of DS-5573a in Japanese Patients With Advanced Solid Malignant Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of subjects experiencing dose limiting toxicities
研究概览
简要总结
This is an open-label, sequential dose escalation and expansion study to evaluate the safety, and pharmacokinetics of DS-5573a in Japanese patients with advanced solid malignant tumors.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
- •Eastern Cooperative Oncology Group performance status(PS) of 0 or 1
排除标准
- •Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:
- •Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, uncontrolled deep-vein thrombosis or clinically severe thromboembolic event, or autoimmune disorders requiring treatment.
- •Severe or uncontrolled concomitant disease.
- •Clinically active brain metastases defined as symptomatic or requiring treatment.
研究组 & 干预措施
DS-5573a does escalation (step 1) and expansion (step 2)
Step 1 of this study will follow a 3+3 study design with a starting intravenous (IV) dose of 0.1 mg/kg.
Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg Step 2: 30 subjects will be enrolled and treated at the dose determined in Step 1.
干预措施: DS-5573a (Drug)
结局指标
主要结局
Number of subjects experiencing dose limiting toxicities
时间窗: Day 1 through Day 28
Number of subjects experiencing dose limiting toxicities. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.
Number of subjects experiencing adverse events
时间窗: Day 1 through 45 days after last dose
Number of subjects experiencing adverse events. To investigate the safety of DS-5573a reporting on frequency and seriousness of treatment emergent adverse events.
Pharmacokinetic profile of DS-5573a
时间窗: Cycle 1 - Day 1 through Cycle 8 - Day 1
Pharmacokinetic profile of DS-5573a. \[Time Frame: Cycle 1, 2, 3: Days 1, 2, 4, 8,15; Cycle 4, 5, 6, 7, 8: Day 1\] To assess the pharmacokinetic profile of DS-5573a in Japanese subjects with advanced malignant solid tumors.
次要结局
- Incidence of human anti-human antibodies (HAHA) against DS-5573a(Cycle 1 - Day 1 through Cycle 1 - Day 15.)
- Assessment of tumor response to DS-5573a using RECIST ver1.1.(week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90)
- Assessment of DS-5573a-related biomarkers in blood and tumor(Cycle 1 - Days 1,2 through Cycle 3 - Days 1,2)