NCT04500587招募中1 期
Phase 1 First in Human Dose-Escalation Study of ZN-d5 as a Single Agent in Subjects With Non-Hodgkin Lymphoma or Acute Myeloid Leukemia
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.14 个研究点 分布在 7 个国家目标入组 115 人开始时间: 2020年10月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 115
- 试验地点
- 14
- 主要终点
- Observed Dose Limiting Toxicities
研究概览
简要总结
Phase 1 dose escalation study of ZN-d5 in subjects with relapsed or refractory non-Hodgkin lymphoma (NHL) or acute myeloid leukemia (AML).
详细描述
This is an open-label multicenter Phase 1 dose escalation study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel BCL-2 inhibitor ZN-d5 in subjects with (NHL) or (AML) in order to determine the recommended phase 2 dose of ZN-d5.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •NHL: relapsed or refractory NHL including DLBCL, FL, MZL, MCL, LCL, LPL and PTC
- •Subjects must have received at least 2 prior lines of therapy and have either failed or not be eligible for any available therapies expected to provide clinical benefit and have measurable disease.
- •AML: Primary, secondary, or treatment-related AML, relapsed or refractory to prior therapy, which may include failure of one cycle of induction therapy.
- •White blood cell count < 25 × 109/L. Cytoreduction prior to treatment is acceptable.
- •Subjects may not be pregnant and must agree to use an effective method of contraception.
- •Eastern Cooperative Oncology Group performance status ≤
- •Estimated life expectancy of at least 12 weeks.
- •Adequate hematologic and organ function, including creatinine clearance ≥ 60 mL/min.
排除标准
- •Recent interventions including major surgery, radiation therapy, stem cell transplant.
- •Treatment with anti-neoplastic agents with 5 half-lives.
- •Significant unresolved toxicity from prior treatments including active GVHD.
- •Active central nervous system disease.
- •Clinically substantial myocardial impairment.
- •Prior therapy with venetoclax.
研究组 & 干预措施
ZN-d5 Single Agent Dose Escalation - NHL
Experimental
Non-Hodgkin Lymphoma
干预措施: ZN-d5 (Drug)
ZN-d5 Single Agent Dose Escalation - AML
Experimental
Acute Myeloid Leukemia
干预措施: ZN-d5 (Drug)
结局指标
主要结局
Observed Dose Limiting Toxicities
时间窗: Through completion of Cycle 1; 1 to 2 months.
Observed Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects.
Incidence and severity of AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v 5.0
时间窗: Through study completion, typically < 12 months
Safety profile of ZN-d5.
次要结局
- For AML, remission rate based on European LeukemiaNet 2017 criteria(Through study completion, typically < 12 months)
- For AML, duration of remission based on European LeukemiaNet 2017 criteria(Through study completion, typically < 12 months)
- Pharmacokinetic parameters for ZN-d5 - Cmax(approximately 6 months)
- Pharmacokinetic parameters for ZN-d5 - Tmax(approximately 6 months)
- Pharmacokinetic parameters for ZN-d5 - AUC(approximately 6 months)
- For NHL, evaluate response according to the Lugano 2014 classification(Through study completion, typically < 12 months)
研究者
研究点 (14)
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