NCT07583212招募中1 期
An Open-Label, Multicenter Phase I Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-1635 in Patients With B-Cell Malignancies.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events.
研究概览
简要总结
The study is being conducted to evaluate the safety and tolerability of HRS-1635. To observe the Dose-Limiting Toxicity (DLT) , explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-1635 in participants with B-cell malignancy.
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
- •Age ≥ 18 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- •Expected survival time ≥ 12 weeks;
- •Histologically or cytologically confirmed relapsed/refractory B-cell malignant tumor;
- •Females of childbearing potential and male participants whose partners are females of childbearing potential must agree to adopt adequate and effective contraceptive measures during the study period. Female participants must not be breastfeeding;
- •Participants voluntarily enroll in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up procedures.
排除标准
- •Tumor infiltration of the central nervous system;
- •A history of other malignant tumors (excluding the study disease) within 2 years prior to the first administration of the study drug;
- •A history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- •Positive for hepatitis B surface antigen (HBsAg) at screening with evidence of viral replication confirmed by HBV-DNA test;
- •Positive for hepatitis C virus antibody (HCV-Ab) at screening with evidence of viral replication confirmed by HCV-RNA test;
- •Positive for human immunodeficiency virus (HIV) antigen/antibody test at screening;
- •History of major surgery or severe trauma within 28 days prior to the first administration of the study drug;
- •Presence of severe cardiovascular disease.;
- •Persistent alcohol or drug abuse;
- •Inability to take oral medication, or presence of severe gastrointestinal dysfunctional diseases, or history of surgery with severe impact on gastrointestinal function.
- •Pregnant or lactating females.
- •Concurrent participation in other interventional clinical trials, or an interval of less than 1 month between the signing date of the informed consent form and the last administration of the study drug in the previous clinical trial;
研究组 & 干预措施
HRS-1635
Experimental
干预措施: HRS-1635 (Drug)
结局指标
主要结局
Incidence and severity of adverse events.
时间窗: approximately 2 year
DLT（Dose-limiting toxicity）
时间窗: approximately 23 days
次要结局
- Area Under the Curve (AUC0-t, AUC0-inf)(15 weeks after treatment initiation)
- Peak Concentration (Cmax)(15 weeks after treatment initiation)
- Half-life (t1/2)(15 weeks after treatment initiation)
- Apparent Clearance (CL/F)(15 weeks after treatment initiation)
- Time to Response (TTR)(approximately 2 year)
- Apparent Volume of Distribution (Vz/F)(15 weeks after treatment initiation.)
- Relative bioavaliability of HRS-1635 in the fed versus fasted state.(48 hours post-dose)
- Objective Response Rate (ORR)(approximately 2 year)
- Duration of Response (DoR)(approximately 2 year)
- Progression-Free Survival (PFS)(approximately 2 year)
- Overall Survival (OS)(approximately 2 year)
- Time to Peak Concentration (Tmax)(15 weeks after treatment initiation)
研究者
研究点 (1)
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