A Phase 1 Study of JNJ-79032421, a T-cell Redirecting Agent Targeting Mesothelin for Advanced Stage Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
研究概览
简要总结
The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-79032421 and to determine the safety and tolerability of JNJ-79032421 at the RP2D(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologically or cytologically confirmed diagnosis of one of the following unresectable/locally advanced or metastatic solid tumors: a) Ovarian cancer includes high grade serous epithelial ovary, fallopian tube, or primary peritoneal cancer. Participants must have progressed after at least 2 prior lines of systemic therapy and have either, i) platinum-refractory disease (ie, persistent disease following completion of platinum-based primary chemotherapy); or ii) platinum-resistant recurrent disease; b) Primary pleural or peritoneal mesothelioma. Sarcomatoid and well differentiated papillary histologies are not allowed. Participants must have progressed after at least 1 prior line of systemic therapy; c) Pancreatic ductal adenocarcinoma. Other histologies and mixed histologies are not allowed. Participants must have progressed after at least 1 prior line of systemic therapy.
- •Measurable or evaluable disease: a) Part 1: Measurable or evaluable disease; b) Part 2: At least one measurable lesion per RECIST v1.
- •Participants with mesothelioma must have disease measurable per mRECIST v1.
- •Can have a prior or concurrent second malignancy (other than the disease under study) whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
- •Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or
- •Selected participants in the pharmacokinetic and pharmacodynamic (PK/PD) cohorts (Part 1) as well as selected participants in Part 2 must agree to undergo mandatory tumor biopsies.
排除标准
- •History of known central nervous system (CNS) or leptomeningeal involvement.
- •Left ventricular ejection fraction on screening echocardiogram below normal institutional limits.
- •History of talc pleurodesis for pleural effusion within 3 months of starting study treatment.
- •Concurrent empyema of the lung pleural space requiring antibiotics or chest tube or evidence of resultant fistula formation.
- •History of hyperthermic intraperitoneal chemotherapy (HIPEC) within 6 months of starting study treatment.
研究组 & 干预措施
Part 1 (Dose Escalation): JNJ-79032421
In Part 1 (Dose escalation), participants will receive JNJ-79032421. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
干预措施: JNJ-79032421 (Drug)
Part 2 (Dose Expansion): JNJ-79032421
In Part 2 (Dose expansion), participants will receive JNJ-79032421 at the RP2D regimen(s) determined in Part 1.
干预措施: JNJ-79032421 (Drug)
结局指标
主要结局
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
时间窗: Up to first 21 days after first dose
The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
时间窗: Up to 3 years
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational product and it does not necessarily have a causal relationship with the investigational product. 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) and immune effector cell-associated neurotoxicity syndrome events (ICANS), which will be graded by 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.
次要结局
- Part 1 and Part 2: Serum Concentration of JNJ-79032421(Up to 3 years)
- Part 1 and Part 2: Maximum Observed Analyte Concentration (Cmax) of JNJ-79032421(Up to 3 years)
- Part 1 and Part 2: Time to Reach Maximum Observed Analyte Concentration (Tmax) of JNJ-79032421(Up to 3 years)
- Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-79032421(Up to 3 years)
- Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-79032421 Antibodies(Up to 3 years)
- Part 1 and Part 2: Objective Response Rate (ORR)(Up to 3 years)
- Part 1 and Part 2: Duration of Response (DOR)(Up to 3 years)
- Part 1 and Part 2: Cancer Antigen (CA) 125 Response Rate for Ovarian Cancer Only(Up to 3 years)