NCT05682170招募中1 期
A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the WEE1 Inhibitor ZN-c3 in Subjects With Acute Myeloid Leukemia
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.13 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 13
- 主要终点
- Observed dose limiting toxicities
研究概览
简要总结
A Phase 1/2 dose escalation study of BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia (AML).
详细描述
This is an open-label multicenter Phase 1/2 dose escalation study, evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel BCL-2 inhibitor ZN-d5 and Wee1 inhibitor ZN-c3 in subjects with AML.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Adults with AML (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy, which may include venetoclax except in Expansion Cohort A
- •ECOG performance status score ≤
- •Projected life expectancy of at least 12 weeks.
- •Estimated glomerular filtration rate ≥60 mL/min
- •Women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs.
- •Men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs.
排除标准
- •Known active CNS involvement
- •Diagnosis of acute promyelocytic leukemia.
- •Peripheral blast count of >25 × 109/L (cytoreduction permitted).
- •Adequate washout from prior therapy including hematopoietic stem cell transplant and recovery from prior treatment-related toxicities to Grade 2 or lower
- •Significant cardiovascular disease
- •Corrected QT interval (QTc) of >480 msec
- •Active hepatitis B or hepatitis C infection
- •Concurrent treatment with strong CYP3A inhibitors or strong or moderate CYP3A inducers
研究组 & 干预措施
Acute Myeloid Leukemia
Experimental
Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination
Phase 2: Dose Expansion
干预措施: ZN-d5 ZN-c3 (Drug)
Acute Myeloid Leukemia
Experimental
Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination
Phase 2: Dose Expansion
干预措施: ZN-c3 (Drug)
结局指标
主要结局
Observed dose limiting toxicities
时间窗: At the end of Cycle 1 (each cycle is 28 days)
Observed Dose Limiting Toxicities (DLTs) in DLT evaluable subjects.
Incidence, severity, and relatedness of adverse events( AEs)
时间窗: Through study completion, typically < 12 months
次要结局
- 2. To investigate the plasma PK of ZN-c3 when given as monotherapy - Area under the plasma concentration-time curve from 0 to 24h(Through study completion, typically < 12 months)
- 5. To investigate the plasma PK of ZN-c3 and ZN-d5 when given in combination - Maximum Plasma Concentration(Through study completion, typically < 12 months)
- Rate and duration or remission according to the European LeukemiaNet 2017 criteria(Through study completion, typically < 12 months)
- 1. To investigate the plasma PK of ZN-c3 when given as monotherapy - Maximum Plasma Concentration(Through study completion, typically <12 months)
- 6. To investigate the plasma PK of ZN-c3 and ZN-d5 when given in combination - Area under the plasma concentration-time curve from 0 to 24h(Through study completion, typically < 12 months)
研究者
研究点 (13)
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