A Phase 1, First-in-Human, Dose Escalation Study of JNJ-63898081, in Subjects With Advanced Stage Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
研究概览
简要总结
The main purpose of this study are to determine the recommended Phase 2 dose (RP2D) regimen and the maximum tolerated dose, and to determine the safety of JNJ-63898081.
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
- •Histology: Part 1: Metastatic castration-resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma. Adenocarcinoma with small-cell or neuroendocrine features is allowed. mCRPC is defined by prostate Cancer Working Group (PCWG )3 criteria. Part 2: mCRPC as defined above or pathologically confirmed metastatic renal cell carcinoma (RCC) as defined by world health organization (WHO) 2016 Classifications
- •Measurable or evaluable disease: Part 1: Either measurable or evaluable disease for prostate cancer. Part 2: At least one measurable lesion as per RECIST v1.
- •Evidence of disease progression on prior therapy that requires a new line of treatment
- •Participants with accessible lesions enrolled in selected pharmacokinetic (PK)/pharmacodynamics (PD) cohorts and in Part 2 must agree to undergo the mandatory fresh tumor biopsies, unless collection of the biopsy presents a safety risk
排除标准
- •Less than 2 weeks between prior anticancer treatment (including radiotherapy) discontinuation and the first dose of study drug, and toxicities have not returned to Grade less than or equal to (<=) 1 or baseline
- •Prior treatment with prostate-specific membrane antigen (PSMA)-targeted therapy except for PSMA-targeted vaccine is permitted
- •Solid organ or bone marrow transplantation
- •Seizure or known condition that may predispose to seizure or intracranial masses
- •Other active malignancy requiring systemic treatment <=12 months prior to enrollment
研究组 & 干预措施
Part 1: Dose Escalation
Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive JNJ-63898081. Ascending dose levels will be sequentially tested.
干预措施: JNJ-63898081 (Drug)
Part 2: Dose Expansion
Participants with mCRPC or renal cell carcinoma (RCC) will receive JNJ-63898081 at the recommended Phase 2 dose (RP2D) determined in Part 1.
干预措施: JNJ-63898081 (Drug)
结局指标
主要结局
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
时间窗: Approximately 3 years
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.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
时间窗: Approximately 3 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: Severity of Adverse Events as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
时间窗: Approximately 3 years
Severity of AEs has 5 grades based on CTCAE criteria: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening consequences; Grade 5: Death.
次要结局
- Part 1 and Part 2: Serum Concentrations of JNJ-63898081(Approximately 3 years)
- Serum Prostate Specific Antigen (PSA) Concentration(Approximately 3 years)
- Objective Response Rate (ORR)(Approximately 3 years)
- Part 1 and 2: Systemic Cytokine Concentrations(Approximately 3 years)
- Duration of Response(Approximately 3 years)
- Part 1 and 2: Number of Participants with JNJ-63898081 Antibodies(Approximately 3 years)