A Phase 1 Clinical Study to Investigate the Safety, Pharmacokinetics and Efficacy of MK-1026 in China Participants With Relapsed or Refractory Hematologic Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 5
- 主要终点
- Number of Participants who Experience Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of oral nemtabrutinib in Chinese participants at least 18 years of age who have Relapsed/Refractory hematologic malignancies.
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
- •Relapsed or refractory participants with a diagnosis of B-cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Leukemia (SLL) or Waldenström's Macroglobulinemia (WM) who have received no more than 4 prior standard systemic therapies. Participants must have failed or are intolerant to standard therapies and cannot be a candidate for standard salvage regimens and those with low grade lymphoma must be progressing and requiring treatment
- •Must have received prior systemic treatment before joining this study
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •HBV/HCV viral load undetectable or no history of HBV/HCV
- •Has adequate organ function
- •Male participants agree to be abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 30 days after the last dose of the study intervention
- •Female participant is not a Women of Child Bearing Potential (WOCBP) or is a WOCBP using contraception during the intervention period and for at least 30 days after the last dose of the study intervention
排除标准
- •Has a history of prior cancer within <3 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, cervical cancer in situ, or other in situ carcinomas
- •Has active primary tumor involvement of central nervous system (CNS) disease
- •Has an active infection requiring systemic therapy
- •Has a known history of Human Immunodeficiency Virus (HIV) infection
- •Has an uncontrolled illness including but not limited to ongoing symptomatic congestive heart failure (New York Heart Association Class III or IV heart failure), unstable angina pectoris, cardiac arrhythmia, and psychiatric illness
- •Had immunotherapy, radioimmunotherapy, biological therapy, chemotherapy, or treatment with an investigational product ≤4 weeks prior to treatment initiation
- •Has any clinically significant gastrointestinal abnormalities that might alter absorption
研究组 & 干预措施
Nemtabrutinib
Participants receive nemtabrutinib at specified dose orally once daily (QD) until progressive disease (PD) or discontinuation.
干预措施: Nemtabrutinib (Drug)
结局指标
主要结局
Number of Participants who Experience Adverse Events (AEs)
时间窗: Up to ~ 35 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of Participants Discontinuing Study Treatment due to AEs
时间窗: Up to ~ 35 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Maximum Concentration (Cmax) of Nemtabrutinib
时间窗: Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 hours post-dose (up to ~57 days). Each cycle is 28 days
Cmax is the maximum concentration of nemtabrutinib observed in plasma. Blood samples collected at designated timepoints will be used to determine Cmax.
Minimum Concentration (Cmin) of Nemtabrutinib
时间窗: Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 hours post-dose (up to ~57 days). Each cycle is 28 days
Cmin is the minimum concentration of nemtabrutinib observed in plasma. Blood samples collected at designated timepoints will be used to determine Cmin.
Area Under the Plasma Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Nemtabrutinib
时间窗: Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 hours post-dose (up to ~57 days). Each cycle is 28 days
AUC0-24 is the area under the curve of plasma concentration of nemtabrutinib from time 0 to 24 hours. Blood samples collected at designated timepoints will be used to determine AUC0-24.
Time to Maximum Concentration (Tmax) of Nemtabrutinib
时间窗: Day 1 of Cycles 1 and 2: Pre-dose,1, 2, 4, 6, 8, and 24 hours post-dose; Day 1 of Cycle 3: pre-dose and 2 hours post-dose (up to ~57 days). Each cycle is 28 days
Tmax is the time to reach maximum concentration of nemtabrutinib. Blood samples collected at designated timepoints will be used to determine Tmax.
次要结局
- ORR per Lugano Criteria 2014 as Assessed by the Investigator(Up to ~ 35 months)
- Duration of Response (DOR) per iwCLL Criteria 2018 as Assessed by the Investigator(Up to ~ 35 months)
- DOR per IWWM Criteria 2014 as Assessed by the Investigator(Up to ~ 35 months)
- Objective Response Rate (ORR) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as Assessed by the Investigator(Up to ~ 35 months)
- DOR per Lugano Criteria 2014 as Assessed by the Investigator(Up to ~ 35 months)
- ORR per International Workshop on Waldenström's Macroglobulinemia (IWWM) Criteria 2014 as Assessed by the Investigator(Up to ~ 35 months)