A Phase 1, First-in-Human, Dose Escalation Study of JNJ-88998377 in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma (NHL)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 29
- 主要终点
- Parts A and B: Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The main purpose of this study is to characterize safety and to determine the recommended phase 2 dose (RP2D) for JNJ-88998377 (Part A: Dose Escalation), to further assess the safety of JNJ-88998377 at the RP2D (Part B: Dose Expansion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 have histologically or cytologically confirmed B-cell non-Hodgkin's Lymphoma (NHL) according to the 2022 World Health Organization (WHO) classification with relapsed or refractory disease
- •Participants have measurable disease or meet all requirements for adequate response assessment as defined by the appropriate disease response criteria at screening
- •Participants have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Participants have a life expectancy of greater than or equal to (>=) 12 weeks
- •Be willing and able to adhere to the lifestyle restrictions specified in the protocol
排除标准
- •Participant with active or prior history of B-cell NHL involving the central nervous system (CNS) and leptomeningeal involvement
- •History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study treatment.
- •For Part A and B: Participant having known allergies, hypersensitivity, or intolerance to the excipients of JNJ-88998377
- •Participant had major surgery or had significant traumatic injury within 30 days before first dose of study treatment or has not recovered from surgery and must not have major surgery planned during the time the participant is receiving study treatment
- •Participant received an autologous stem cell transplant less than or equal to (<=) 3 months before the first dose of study treatment
研究组 & 干预措施
Part A: Dose Escalation
Participants will receive JNJ-88998377 at a selected starting dose. Subsequent dose levels and schedules will be selected based on the review of all available data to establish recommended Phase 2 dose (RP2D).
干预措施: JNJ-88998377 (Drug)
Part B: Dose Expansion
Participants will receive JNJ-88998377 at RP2D determined in Part A. Additional expansion cohort(s) may be added with a lower RP2D(s), or different dose schedule(s) based on all available data.
干预措施: JNJ-88998377 (Drug)
结局指标
主要结局
Parts A and B: Number of Participants with Adverse Events (AEs)
时间窗: Upto 3 years 4 months
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non-investigational) product. It does not necessarily have a causal relationship with the investigational product.
Part A: Number of Participants with Dose Limiting Toxicity (DLTs)
时间窗: Cycle 1 (21 days)
Number of participant with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematological or hematological toxicity.
次要结局
- Percentage of Participants With Overall Response (OR)(Up to 3 years 4 months)
- Time to Response (TTR)(From first dose of study treatment until first response of PR or better (up to 3 years and 4 months))
- Duration of Response (DOR)(From date of documentation of first response of PR or better until progressive disease or death (up to 3 years and 4 months))
- Plasma Concentration of JNJ-88998377(Up to first 12 weeks)
- Minimum Plasma Drug Concentration (Cmin) of JNJ-88998377(Up to first 12 weeks)
- Area Under the Plasma Concentration Versus Time Curve During A Dosing Interval (τ) At Steady-State of JNJ-88998377(Up to first 12 weeks)
- Maximum Plasma Concentration (Cmax) of JNJ-88998377(Up to first 12 weeks)