NCT07658352尚未招募1 期
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
Shanghai Helioson Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2026年6月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
研究概览
简要总结
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
- •Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-
- •Patients with relapsed or refractory B-cell non-Hodgkin lymphoma subtypes (CLL/SLL, MCL, MZL, DLBCL, FL, WM, and PCNSL).
排除标准
- •Prior use of a BTK protein degrader.
研究组 & 干预措施
expansion cohort 5
Experimental
干预措施: HP-002 (Drug)
expansion cohort 3
Experimental
干预措施: HP-002 (Drug)
expansion cohort 4
Experimental
干预措施: HP-002 (Drug)
escalation part
Experimental
干预措施: HP-002 (Drug)
expansion cohort 1
Experimental
干预措施: HP-002 (Drug)
expansion cohort 2
Experimental
干预措施: HP-002 (Drug)
研究者
研究点 (1)
Loading locations...
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