A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- Parts 1 and 2: Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (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
- Male
- 接受健康志愿者
- 否
入选标准
- •Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
- •Measurable or evaluable disease
- •At least 1 prior treatment for mCRPC
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ functions as defined by certain laboratory values
- •Must sign an informed consent form (ICF)
- •Participants must agree to use a highly effective form of birth control as guided by the study doctor
排除标准
- •Concurrent anticancer therapy
- •Severe or long-lasting side effects related to prior anticancer therapy
- •Known allergies to JNJ-80038114 or its excipients
- •Brain metastasis or known seizure history
- •Significant infections or lung, heart or other medical conditions
研究组 & 干预措施
Part 1: Dose Escalation
Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET).
干预措施: JNJ-80038114 (Drug)
Part 2: Dose Expansion
Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1.
干预措施: JNJ-80038114 (Drug)
结局指标
主要结局
Parts 1 and 2: Number of Participants With Adverse Events (AEs)
时间窗: Up to 2 Years 6 Months
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.
Parts 1 and 2: Number of Participants With AEs by Severity
时间窗: Up to 2 Years 6 Months
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
时间窗: Up to 2 Years 6 Months
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
次要结局
- Serum Prostate Specific Antigen (PSA) Concentration(Up to 2 Years 6 Months)
- Serum Concentration of JNJ-80038114(Up to 2 Years 6 Months)
- Systemic Cytokine Concentrations(Up to 2 Years 6 Months)
- Objective Response Rate (ORR)(Up to 2 Years 6 Months)
- PSA Response Rate(Up to 2 Years 6 Months)
- Duration of Response (DOR)(Up to 2 Years 6 Months)
- Number of Participants With Antibodies to JNJ-80038114(Up to 2 Years 6 Months)