An Open-label, Multicenter Phase 1 Study to Characterize Safety, Tolerability, Preliminary Antitumor Activity, Pharmacokinetics, and Pharmacodynamics of VIP943 Monotherapy in Subjects With Advanced CD123+ Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Incidence of DLT (Dose limit toxicity) of VIP943
研究概览
简要总结
Dose Escalation - Determine the maximum tolerated dose (MTD), if possible, or minimum optimal biologic dose (OBD), and evaluate the safety and tolerability of VIP943 in subjects with advanced CD123+ hematologic malignancies
详细描述
Relapsed or refractory AML, MDS, or B-ALL subjects who are CD123 positive. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed AML, B-ALL or MDS. Subjects must have exhausted all available standard therapies or be deemed ineligible for potential available therapies.
- •Evidence of ≥5% bone marrow or blood blasts (acute leukemia) or ≥5% bone marrow or blood myeloblasts (MDS) to allow for assessment of drug activity.
- •Evidence of CD123 expression from a local laboratory.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
排除标准
- •Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Clinically significant cardiac disease including congestive heart failure > New York Heart Association (NYHA) Class II), evidence for coronary artery disease (eg, unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose.
研究组 & 干预措施
Dose Escalation of VIP943 (QW)
Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration weekly (QW).
干预措施: VIP943 (QW) (Drug)
Dose Escalation of VIP943 (BIW)
Subjects with AML, MDS, and B-ALL with CD123 expression will be administered VIP 943 in sequential ascending doses as a monotherapy via intravenous (IV) administration twice weekly (BIW).
干预措施: VIP943 (BIW) (Drug)
结局指标
主要结局
Incidence of DLT (Dose limit toxicity) of VIP943
时间窗: Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days
次要结局
- Response rate to VIP943 as assessed by investigators using disease-specific response criteria(Cycle 1 Day 1 up to 30 days after the last dose, where each cycle is up to 28 days (up to approximately 10 months))
- Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of VIP943(Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days)
- Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of VIP943(Cycle 1 Day 1 through Cycle 2 Day 1, where each cycle is up to 28 days)