A Phase 1 Study of JNJ-87890387, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 (ENPP3) x CD3 Bispecific Antibody, for Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
研究概览
简要总结
The purpose of this study is to determine safety and recommended phase 2 dose(s) (RP2Ds) of JNJ-87890387 and to determine the safety of JNJ-87890387 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
- •Have histologically or cytologically confirmed, metastatic, or unresectable solid tumor of one of the following types: a) Renal cell cancer (RCC)-clear cell or papillary carcinoma; b) Endometrioid ovarian cancer c) Endometrioid uterine carcinoma; d) Colorectal adenocarcinoma (CRC); e) Lung adenocarcinoma
- •Have measurable or evaluable disease: Part 1- Either measurable or evaluable disease; Part 2- At least 1 measurable lesion per RECIST v1.
- •Participants with ovarian cancer without a measurable lesion must have disease evaluable per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or have cancer antigen (CA) 125 greater than (>) 2*upper limit of normal (ULN) during screening
- •All participants in Part 1 and Part 2 must consent to provide an archived tumor tissue sample at screening
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at screening
- •Be willing and able to adhere to the lifestyle restrictions specified in this protocol.
排除标准
- •Active Central Nervous System (CNS) involvement with the exception of locally treated brain metastases that are clinically stable and asymptomatic for > 2 weeks and who are off or receiving low-dose corticosteroid treatment (less than or equal to [<=]10 milligrams [mg] prednisone or equivalent) for at least 2 weeks prior to start of study treatment
- •Toxicity from prior anticancer therapy that has not resolved to Grade <=1 (except alopecia, vitiligo, Grade <=2 peripheral neuropathy, or endocrinopathies that are stable on hormone replacement)
- •History of Grade greater than or equal to (>=) 2 immune-related AE(s) with prior immunotherapy that led to discontinuation of previous immunotherapy with the exception of Grade 2 and Grade 3 immune-related AEs that responded to treatment and that did not recur following rechallenge. Endocrinopathies that are stable on hormone replacement therapy or that have resolved are allowed.
- •History of solid organ or hematologic stem cell transplantation
- •Any episode of partial or complete bowel obstruction requiring hospitalization within 30 days prior to first dose of study treatment
研究组 & 干预措施
JNJ-87890387
In Part 1 (Dose escalation) participants will receive JNJ-87890387. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified. In Part 2 (Dose expansion), participants will receive JNJ-87890387 at the RP2D regimen(s) determined in Part 1.
干预措施: JNJ-87890387 (Drug)
结局指标
主要结局
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
时间窗: Up to 2 years 9 months
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.
Part 1: Number of Participants with Dose Limiting Toxicity (DLTs)
时间窗: Up to first 21 days after administration of the first full treatment dose
Number of participants with DLTs will be reported. The DLTs are adverse events including certain high grade non-hematologic or hematologic toxicities, or toxicities meeting other specific criteria.
次要结局
- Part 1 and Part 2: Serum Concentration of JNJ-87890387(Up to 2 years 9 months)
- Part 1 and Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-87890387(Up to 2 years 9 months)
- Part 1 and Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-87890387(Up to 2 years 9 months)
- Part 1 and Part 2: Area Under the Curve from Time t1 to Time t2 (AUC[t1-t2]) of JNJ-87890387(Up to 2 years 9 months)
- Part 1 and Part 2: Duration of Response (DOR)(Up to 2 years 9 months)
- Part 1 and Part 2: Area Under the Curve from Time Zero to Time tau (AUC[0-tau]) of JNJ-87890387(Up to 2 years 9 months)
- Part 1 and Part 2: Minimum Observed Serum Concentration (Cmin) of JNJ-87890387(Up to 2 years 9 months)
- Part 1 and Part 2: Number of Participants with Presence of Anti-JNJ-87890387 Antibodies(Up to 2 years 9 months)
- Part 1 and Part 2: Objective Response Rate (ORR)(Up to 2 years 9 months)
- Part 1 and Part 2: Accumulation Ratio of JNJ-87890387(Up to 2 years 9 months)