A Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 14
- 主要终点
- Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
研究概览
简要总结
The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Participants must have Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- •Participants must have cardiac parameters within the following range: corrected QT interval (QTcF) less than or equal to <= 480 milliseconds based on the average of triplicate assessments performed as close as possible in succession (the full set of triplicates should be completed in less than 10 minutes)
- •Women of childbearing potential must have a negative highly sensitive serum pregnancy test (example: beta human chorionic gonadotropin [beta-hCG]) at screening, and a negative serum or urine pregnancy test prior to the first dose of study drug
- •Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug administration
- •Participants must be willing and able to adhere to the lifestyle restrictions specified in this protocol
排除标准
- •Participant has known active central nervous system (CNS) involvement
- •Participant has received prior solid organ transplantation
- •Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or its excipients
- •Participant has been treated with an investigational drug (including investigational vaccines) within five half-lives or 2 weeks before the planned first dose of study drug
- •Participant is experiencing toxicities from previous anticancer therapies that have not resolved to baseline levels, or to Grade 1 or less (except for alopecia and peripheral neuropathy)
研究组 & 干预措施
JNJ-64264681: Dose Escalation and Expansion
Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2).
干预措施: JNJ-64264681 (Drug)
结局指标
主要结局
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
时间窗: Up to 21 days
The DLTs are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher (as specified in protocol).
Part 1 and Part 2: Number of Participants with Adverse Events (AEs)
时间窗: Up to 2 years
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
次要结局
- Plasma Concentration of JNJ-64264681(Up to 2 years)
- Percentage Occupancy of the Target(Up to 2 years)
- Overall Response Rate (ORR)(Up to 2 years)
- Time to Response (TTR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Complete Response (CR) Rate(Up to 2 years)
- Progression-free Survival (PFS)(Up to 2 years)