A Phase 1, Multicenter, First-in-human Study of DS-1471a In Subjects With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 5
- 主要终点
- Number of Participants With Dose-limiting Toxicities Following Treatment With DS-1471a (Dose Escalation)
研究概览
简要总结
This first-in-human (FIH) study will assess the safety, preliminary efficacy, pharmacokinetics (PK), and immunogenicity of DS-1471a in participants with advanced or metastatic solid tumors.
详细描述
The objectives of this multinational, multicenter, open-label, 2-part, dose-escalation and dose-expansion, FIH study of participants with locally advanced or metastatic solid tumors are to evaluate the safety, maximum tolerated dose (MTD), recommended dose for expansion phase, preliminary efficacy, PK, and immunogenicity of DS-1471a.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1, Dose Escalation Cohort 1: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
干预措施: DS-1471a (Drug)
Part 1, Dose Escalation Cohort 2: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
干预措施: DS-1471a (Drug)
Part 1, Dose Escalation Cohort 3: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
干预措施: DS-1471a (Drug)
Part 1, Dose Escalation Cohort 4: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
干预措施: DS-1471a (Drug)
Part 1, Dose Escalation Cohort 5: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
干预措施: DS-1471a (Drug)
Part 1, Dose Escalation Cohort 6: DS-1471a
Participants with locally advanced or metastatic tumors will receive intravenous DS-1471a.
干预措施: DS-1471a (Drug)
Part 2, Dose Expansion (Tumor-specific Cohort 1): DS-1471a
Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
干预措施: DS-1471a (Drug)
Part 2, Dose Expansion (Tumor-specific Cohort 2): DS-1471a
Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
干预措施: DS-1471a (Drug)
Part 2, Dose Expansion (Tumor-specific Cohort 3): DS-1471a
Participants will receive intravenous DS-1471a at the maximum tolerated dose and/or recommended dose for expansion as established in Part 1 Dose Escalation.
干预措施: DS-1471a (Drug)
结局指标
主要结局
Number of Participants With Dose-limiting Toxicities Following Treatment With DS-1471a (Dose Escalation)
时间窗: Cycle 1: Baseline up to Day 28 (each cycle is 28 days)
Number of Participants With Treatment-emergent Adverse Events Following Treatment With DS-1471a (Dose Escalation and Expansion)
时间窗: Baseline up to 60 months
次要结局
- Time to Response (TTR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Best Overall Response (BOR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Objective Response Rate (ORR) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Expansion)(Baseline up to 60 months)
- Pharmacokinetic Analysis Maximum Plasma Concentration (Cmax) of DS-1471a(Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days)
- Duration of Response (DoR) As Assessed by the Investigator in Participants Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Overall Survival (OS) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Progression-free Survival (PFS) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Escalation and Expansion)(Baseline up to 60 months)
- Disease Control Rate (DCR) of Participants With Advanced Solid Tumors Following Treatment With DS-1471a (Dose Expansion)(Baseline up to 60 months)
- Pharmacokinetic Analysis Time to Reach Maximum Plasma Concentration (Tmax) of DS-1471a(Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days)
- Pharmacokinetic Analysis Trough Plasma Concentration (Ctrough) of DS-1471a(Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days)
- Pharmacokinetic Analysis Area Under the Plasma Concentration-Time Curve of DS-1471a(Cycle 1 (Days 1, 2, 4, 8, 15, and 22), Cycle 2 (Day 1), Cycle 3 (Days 1, 2, 4, 8, 15, and 22), Cycles 4, 6, and 8 (Day 1), each cycle is 28 days)
- Percentage of Participants With Anti-Drug Antibodies Against DS-1471a(Cycle 1 (Days 1 and 8), Cycle 2 and 3 (Day 1), and Cycle 4 and every 2 cycles thereafter (Day 1), each cycle is 28 days)
研究者
Clinical Trial Office
Scientific
Daiichi Sankyo Co. Ltd.