Study of the Anti-EphA3 Monoclonal Antibody KB004 in Subjects With EphA3-Expressing Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 120
- 主要终点
- Phase 1: Determine a possible maximum tolerated dose (MTD)
研究概览
简要总结
This is a global, multicenter, open-label, repeat-dose, Phase 1/2 study consisting of a Dose Escalation Phase (Phase 1) and a Cohort Expansion Phase (Phase 2). In both phases, KB004 will be administered by IV infusion once weekly as part of a 21-day dosing cycle.
详细描述
The purpose of Phase 1 is to determine a maximum tolerated dose (MTD) for KB004 when administered to subjects with hematologic malignancies who meet the entry criteria. Phase 1 has completed enrollment July of 2014, the recommended Phase 2 dose is 250 mg. AML 20 mg Cohort completed enrollment Dec 2014.
The purpose of Phase 2 is to characterize preliminary clinical activity. The Phase 2 portion of the study consists of two parts:
- Part A: Subjects with AML or MDS who meet the entry criteria
- Part B: Subjects with MF who meet the entry criteria
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phase 1 dose levels: KB004
IV infusion 1x Weekly for a 21 day dosing cycle
Subjects with heme malignancies will be assigned to one of 11 planned KB004 (dose levels (20mg, 40mg, 70mg, 100mg, 140mg, 190mg, 250mg, 330mg)
干预措施: KB004, Monoclonal Antibody (Drug)
Phase 2 dose levels: KB004
IV infusion 1x Weekly for a 21 day dosing cycle
Subjects will be assigned to the recommended Phase 2 dose of 250 mg
干预措施: KB004, Monoclonal Antibody (Drug)
结局指标
主要结局
Phase 1: Determine a possible maximum tolerated dose (MTD)
时间窗: Once weekly for the first three weeks of study treatment
Phase 2: To characterize preliminary clinical activity based on the International Working Group (IWG) criteria specific to the hematologic malignancy
时间窗: Evaluations at designated timepoints
次要结局
- Phase 1/2: Assess immunogenicity(Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles)
- Phase 1/2: Safety and Tolerability(Duration of study participation)
- Phase 1: Examine clinical activity(Evaluations at designated timepoints)
- Phase 1/2: Pharmacokinetic profile(Cycle 1: multiple timepoints. Thereafter, single samples at designated cycles)