A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Confirmed adenocarcinoma of the prostate which has spread to other body parts
- •Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
- •Measurable or evaluable disease
- •Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog
排除标准
- •Disease conditions
- •Active central nervous system (CNS) involvement
- •Toxicity related to prior anticancer therapy has not adequately recovered
- •Prior/Concomitant Therapy
- •Prior treatment with human kallikrein (KLK) 2-targeted therapy
- •Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug
- •Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug
- •Prior/Concurrent Medical Conditions
- •Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug
- •Solid organ or bone marrow transplantation
- •Major clotting diseases within one month prior to the first dose of study drug
- •Active autoimmune disease within 12 months prior to the first dose of study drug
- •Active infection
- •Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug
- •Clinically significant lung diseases
- •Active or chronic hepatitis B or hepatitis C infection
- •Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load)
- •Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatme
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 1 year and 10 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.
Number of Participants With AEs by Severity
时间窗: Up to 1 year and 10 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 immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Number of Participants With Dose-Limiting Toxicity (DLT)
时间窗: Up to 1 year and 10 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 Concentration of JNJ-78278343(Up to 1 year and 10 months)
- Systemic Cytokine Concentrations(Up to 1 year and 10 months)
- Serum Prostate Specific Antigen (PSA) Concentration(Up to 1 year and 10 months)
- Number of Participants With Anti-JNJ-78278343 Antibodies(Up to 1 year and 10 months)
- Objective Response Rate (ORR)(Up to 1 year and 10 months)
- Radiographic Progression-free Survival (rPFS)(Up to 1 year and 10 months)
- PSA Response Rate(Up to 1 year and 10 months)
- Duration of Response (DOR)(Up to 1 year and 10 months)