A Phase 1 Study of JNJ-89862175, an Ectonucleotide Pyrophosphatase/Phosphodiesterase Family Member 3 Antibody Drug Conjugate, for Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 6
- 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 safe and effective dose (recommended phase 2 doses [RP2Ds]) of JNJ-89862175 in Part 1 (dose escalation), and to further evaluate how safe JNJ-89862175 is at the RP2Ds in Part 2 (dose expansion) in participants with advanced stage solid tumors.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 序贯
- 主要目的
- 治疗
- 盲法
- 开放(无盲法)
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
- Participants must have histologically or cytologically confirmed, metastatic or unresectable solid tumor of lung adenocarcinoma, renal cell carcinoma (RCC): clear cell or papillary carcinoma, endometrioid ovarian cancer and endometrioid uterine carcinoma
- Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1 at screening
- Participants on study drug and for 4 months after the last dose of study drug must not breastfeed or be pregnant, not donate gametes (that is, eggs or sperms) or freeze for future use for the purposes of assisted reproduction and wear an external condom
排除标准
- Active central nervous system (CNS) involvement unless clinically stable
- History of clinically significant cardiovascular disease within 6 months prior to signing informed consent
- History of solid organ or hematologic stem cell transplantation
- Known allergies, hypersensitivity, or intolerance to excipients of JNJ-89862175
- Has prior or concurrent second malignancy (other than the disease under study) in which the natural history or treatment is likely to interfere with safety endpoints or efficacy of the study drug
研究组 & 干预措施
JNJ-89862175
Participants will receive JNJ-89862175 in Part 1 to determine the recommended phase 2 doses (RP2Ds). Dose-escalation and de-escalation will be based on study evaluation team (SET) decision. In Part 2, participants will receive JNJ-89862175 at the RP2Ds determined in Part 1.
干预措施: JNJ-89862175 (Drug)
结局指标
主要结局
Part 1: Number of Participants with Dose-Limiting Toxicity (DLTs)
时间窗: Up to 21 days
The DLTs are specific adverse events that includes high grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation.
Part 1: Number of Participants with Adverse Events (AEs) by Severity
时间窗: Up to 2 years and 10 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. 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.
Part 2: Number of Participants with Adverse Events (AEs) by Severity at RP2D
时间窗: Up to 2 years and 10 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product and does not necessarily have a causal relationship with the intervention. Severity will be graded according to the 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.
次要结局
- Objective Response Rate (ORR)(Up to 2 years and 10 months)
- Progression Free Survival (PFS)(Up to 2 years and 10 months)
- Duration of Response (DOR)(Up to 2 years and 10 months)
- Time to Reach Cmax (Tmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)(Up to 2 years and 10 months)
- Area Under the Plasma Concentration - Time (AUC [0-t]) Curve for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)(Up to 2 years and 10 months)
- Maximum Plasma Concentration (Cmax) for JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)(Up to 2 years and 10 months)
- Observed Plasma Concentration Immediately Before Next Dose Administration (Ctrough) of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)(Up to 2 years and 10 months)
- Accumulation Ratio of JNJ-89862175 (Total and Conjugated Antibody, Free Payload and Major Metabolite)(Up to 2 years and 10 months)
- Number of Participants With Anti JNJ-89862175 Antibodies(Up to 2 years and 10 months)
研究者
研究点 (6)
标识符
- NCT 编号
- NCT07223125
- 其他研究编号
- 89862175LUC1001, 89862175LUC1001, 2025-521407-52-00, 2025
日期
- 首次提交
- (11个月前)
- 首次发布
- (11个月前)
- 主要完成日期
- (2个月后)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
