A Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This is a Phase I Clinical Study to Evaluate the Safety, Efficacy, and PK/PD Characteristics of HSK47977 Tablets in Subjects with Relapsed or Refractory Non-Hodgkin's Lymphoma.This study includes a Phase Ia dose-escalation stage and a Phase Ib dose-expansion stage, and it is expected to take approximately 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Voluntarily sign the informed consent form.
- •Age ≥18 years, with no gender restriction.
- •Pathologically confirmed patients with relapsed/refractory Non-Hodgkin Lymphoma (rrNHL).
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to
- •Expected survival >3 months.
- •Presence of measurable lesions.
- •Adequate organ function.
- •Agreement to undergo pathological tissue biopsy.
- •Subjects of childbearing potential must agree to comply with the contraceptive requirements of the study.
- •No pregnancy plans from screening until at least 3 months after the last dose of the study drug, and voluntary use of effective contraceptive measures.
排除标准
- •Concurrent presence of other severe, unstable diseases/conditions that, in the investigator's judgment, make participation in this study unsuitable.
- •History of or current severe cardiovascular disease.
- •Poorly controlled blood pressure during the screening period.
- •Laboratory abnormalities identified by the investigator that may pose a risk to the subject's safety.
- •Electrocardiogram abnormalities determined by the investigator as potentially posing a risk to the subject's safety.
- •History of allergies to the investigational drug or its excipients.
- •Inability to discontinue prohibited medications as specified in the protocol during the screening period and throughout the entire study duration.
- •Any other conditions that may increase subject risk or interfere with the trial results.
- •Any other situations where the investigator deems the subject unsuitable for participation.
研究组 & 干预措施
Phase Ia (Dose Escalation Part): HSK47977
Phase 1a (Dose Escalation Part): dose escalation of HSK47977 at various dose levels
干预措施: HSK47977 (Drug)
Phase Ia (Extension Part): HSK47977
Phase 1a (Part B): dose extention of HSK47977 at certain dose levels
干预措施: HSK47977 (Drug)
Phase Ib: HSK47977
Phase 1b: dose expansion for HSK47977 at dose of RP2D（Recommended Phase II Dose）
干预措施: HSK47977 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Within first 28 days of treatment
Highest dose level at which under 33% of patients in a cohort experience DLT（dose limiting toxicity）
次要结局
未报告次要终点