Phase I Study of HRS-3738 in Recurrent and Refractory Non-Hodgkin's Lymphoma and Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-3738 in patients with recurrent and refractory Non-Hodgkin's lymphoma and multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Active multiple myeloma in accordance with IMWG criteria，or histopathologically and immunohistochemically confirmed non-Hodgkin's lymphoma in accordance with the 2016 WHO Classification of lymphoid neoplasias.
- •Recurred or did not alleviate after the previous treatment.
- •Have at least one measurable lesion.
- •With a life expectancy of ≥3 months.
- •Male or female ≥ 18 years old.
- •ECOG performance status of 0-
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
排除标准
- •Amyloidosis, plasma cell leukemia.
- •Corrected serum calcium>3.4mmol/L(13.5mg/dl).
- •Presence of metastasis to central nervous system.
- •Treatment of other investigational products.
- •Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.
- •Known history of hypersensitivity to any components of HRS-
- •Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.
研究组 & 干预措施
HRS-3738
In dose Escalation:
HRS-3738 will be taken in oral. Seven dose levels are preset.
In dose Expansion:
2 to 3 dose cohorts will be selected for dose expansion stage.
In indication Expansion:
Indications will be selected to evaluate preliminary efficacy.
干预措施: HRS-3738 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: From Day 1 to Day 28
Incidence and category of dose limiting toxicities (DLTs) during the first 28-day cycle of HRS-3738 treatment.
RP2D
时间窗: From Day 1 to Day 28
RP2D will be determined on the basis of evaluation on safety, PK, efficacy data in dose escalation and dose expansion stages.
次要结局
- Safety endpoints: adverse events(AEs), serious adverse events（SAEs）(From Day 1 to 30 days after last dose.)
- Efficacy endpoints: Overall response rate (ORR)(From Day 1 to 30 days after last dose.)
- Efficacy endpoints: Best of response (BOR)(From Day 1 to 30 days after last dose)
- Efficacy endpoints: time to response (TTR)(From Day 1 to 30 days after last dose.)
- Efficacy endpoints: Duration of response (DoR)(From Day 1 to 30 days after last dose)
- Efficacy endpoints: Progression-free survival (PFS)(From Day 1 to 30 days after last dose)
- Efficacy endpoints: overall survival (OS).(From Day 1 to 30 days after last dose.)
- Cmax(From Day 1 to 30 days after last dose)
- Tmax(From Day 1 to 30 days after last dose)
- AUC(From Day 1 to 30 days after last dose)
- t1/2(From Day 1 to 30 days after last dose)
- Vz/F(From Day 1 to 30 days after last dose)
- CL/F(From Day 1 to 30 days after last dose)