Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Drug clearance (CL)
研究概览
简要总结
This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid 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, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),
- •Severe or uncontrolled concomitant disease.
- •Clinically active brain metastases defined as symptomatic or requiring treatment.
研究组 & 干预措施
DS-1123
This study will follow a modified Continual Reassessment Method (mCRM) + Escalation with Overdose Control (EWOC),design with a starting intravenous (IV) dose of 0.1 mg/kg.
干预措施: DS-1123 (Drug)
结局指标
主要结局
Drug clearance (CL)
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
Mean residence time (MRTinf)
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
Elimination rate constant (Kel)
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCinf)
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
Area under the curve (AUCtau)
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
Maximum concentration (Cmax)
时间窗: Cycles 1, 2 : Days 1,2, 4, 8, 15
Time of maximum concentration (Tmax)
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
Half-life (T1/2)
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
Number and severity of treatment emergent adverse events (TEAEs)
时间窗: Day 1 to Day 31
area under the curve AUClast
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
pharmacokinetics profile
Volume of distribution (Vz)
时间窗: Cycles 1, 2: Days 1,2, 4, 8, 15
次要结局
- DS-1123a antibody(Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date)
- Change in Cytokines expression(Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2)