A Phase 1 Study of JNJ-70218902, a T Cell Redirecting Agent, in Advanced Stage Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 14
- 主要终点
- Part 1 and Part 2: Number of Participants with AEs by Severity
研究概览
简要总结
The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) and maximum tolerated dose (MTD) of JNJ-70218902 in Part 1, and to determine the safety of JNJ-70218902 RP2D(s) in Part 2.
详细描述
JNJ-70218902, the investigational drug, has been shown in pre-clinical studies to work by attaching to cancer cells and activating immune cells to kill these cancer cells. This study will be conducted in 2 parts: dose escalation (Part 1) and dose expansion (Part 2) and will enroll adult men with Metastatic Castration-Resistant Prostate Cancer (MCRPC). Study evaluations will include preliminary clinical efficacy, safety, pharmacokinetics, biomarkers and immunogenicity evaluations. This study is divided into 3 periods: screening, treatment and post-treatment. The total duration of the study will be 2.5 years approximately.
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
- •Histology: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed
- •Measurable or evaluable disease
- •Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
- •If the participant is receiving treatment with gonadotropin-releasing hormone agonists or antagonist analogs (GnRH), this therapy must have been initiated prior to first dose of study drug and must be continued throughout the study
- •Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- •Adequate organs functions
排除标准
- •Known brain metastases
- •Concurrent use of any other anticancer treatment or investigational agent for the treatment of advanced disease
- •Toxicities related to prior anticancer treatments have not returned to Grade less than or equal to (<=) 1 or baseline, except for alopecia and vitiligo
- •Solid organ or bone marrow transplantation
- •Known allergies, hypersensitivity, or intolerance to JNJ-70218902 or its excipients
- •Certain comorbidities
研究组 & 干预措施
Part 2: Dose Expansion
Participants with mCRPC will receive JNJ-70218902 at the RP2D determined in Part 1.
干预措施: JNJ-70218902 (Drug)
Part 1: Dose Escalation
Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-70218902. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
干预措施: JNJ-70218902 (Drug)
结局指标
主要结局
Part 1 and Part 2: Number of Participants with AEs by Severity
时间窗: Up to 2.5 years
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS), which will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. 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.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Up to 2.5 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.
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
时间窗: Up to 21 days
Number of participants with DLT will be assessed. 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
- Maximum Observed Serum Concentration (Cmax) of JNJ-70218902(Up to 2.5 years)
- Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-70218902(Up to 2.5 years)
- Accumulation Ratio (RA) of JNJ-70218902(Up to 2.5 years)
- Systemic Cytokine Concentrations(Up to 2.5 years)
- Serum Prostate Specific Antigen (PSA) Concentration(Up to 2.5 years)
- Number of Participants With Anti-JNJ-70218902 Antibodies(Up to 2.5 years)
- Area Under the Serum Concentration-time Curve From t1 to t2 Time (AUC[t1-t2]) of JNJ-70218902(Up to 2.5 years)
- Minimum Observed Serum Concentration (Cmin) of JNJ-70218902(Up to 2.5 years)
- Duration of Response (DOR)(Up to 2.5 years)
- Area Under the Concentration-time Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-70218902(Up to 2.5 years)
- Objective Response Rate (ORR)(Up to 2.5 years)