A First-in-Human Study of HP-002 for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
An Open-label, First-in-human Dose Escalation and Dose Expansion Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HP-002 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
This is an open-label, first-in-human dose escalation and dose expansion Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HP-002 in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma This study consists of two phases: a dose-exploration phase and a dose-expansion phase.
The safety and tolerability of HP-002 will be evaluated in Phase 1 study, as well as the maximum tolerated dose (MTD) and the recommended dose level for Phase 2 study will be determined.
The efficacy of HP-002 will be evaluated in Phase 2 study.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名：Yunju Yi
- 电话号码：+8613518115493 +86
- 邮箱：yiyunju@eastonpharma.cn
学习地点
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Guangdong
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Guangzhou、Guangdong、中国
- Sun Yat-sen University Cancer Center
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
- Patients with relapsed or refractory B-cell non-Hodgkin lymphoma subtypes (CLL/SLL, MCL, MZL, DLBCL, FL, WM, and PCNSL).
Exclusion Criteria:
- Prior use of a BTK protein degrader.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：escalation part
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HP-002 will be taken once daily, at approximately the same time each morning.
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实验性的：expansion cohort 1
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HP-002 will be taken once daily, at approximately the same time each morning.
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实验性的：expansion cohort 2
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HP-002 will be taken once daily, at approximately the same time each morning.
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实验性的：expansion cohort 3
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HP-002 will be taken once daily, at approximately the same time each morning.
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实验性的：expansion cohort 4
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HP-002 will be taken once daily, at approximately the same time each morning.
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实验性的：expansion cohort 5
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HP-002 will be taken once daily, at approximately the same time each morning.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Dose-limiting toxicities (DLTs)
大体时间：28 days after the first dose
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28 days after the first dose
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Adverse events (AEs)
大体时间：up to 5 years
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up to 5 years
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Overall Response Rate (ORR)
大体时间：up to 5 years
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up to 5 years
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.