Phase 1 Study of Intratumoral Administration of JNJ-87704916, an Oncolytic Virus, as Monotherapy and in Combination for Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 126
- 试验地点
- 18
- 主要终点
- 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 the safety, feasibility, recommended dose(s) and regimen(s) of JNJ-87704916 as monotherapy and in combination with cetrelimab.
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
- •For Part 1: Individuals with a diagnosis of advanced or metastatic solid tumor exhausting all available standard of care therapy; Part 2: Individuals with histologically or cytologically confirmed metastatic or locally advanced NSCLC
- •Have at least 1 injectable tumor
- •Eastern cooperative oncology group (ECOG) performance status of grade 0 or 1
- •A participant who can have children must have a negative pregnancy test before the first dose of study treatment and during the study
- •Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
排除标准
- •Active disease involvement of the CNS (example, primary central nervous system tumors, metastases, leptomeningeal disease). Some exceptions are allowed
- •Prior history of, or active, significant herpetic infections (example, herpetic keratitis or encephalitis) or active herpetic infections that require ongoing systemic anti-viral therapy
- •Active infection or condition that requires treatment with systemic anti-infective agents (example, antibiotics, antifungals, or antivirals) within 7 days prior to the first dose of study treatment or chronic use of anti-infective agents
- •History of solid organ or hematologic stem cell transplantation
- •Known positive test result for human immunodeficiency virus (HIV) or other immunodeficiency syndrome
- •History of allergy to protein-based therapies or history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia)
研究组 & 干预措施
Part 1: Dose Escalation
Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested.
干预措施: JNJ-87704916 (Drug)
Part 2: Dose Expansion
Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC.
干预措施: Cetrelimab (Drug)
Part 1: Dose Escalation
Participants with advanced solid tumors will receive JNJ-87704916 alone and in combination with cetrelimab. Ascending dose levels will be sequentially tested.
干预措施: Cetrelimab (Drug)
Part 2: Dose Expansion
Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC.
干预措施: JNJ-87704916 (Drug)
Part 2: Dose Expansion
Part 2 will consist of three cohorts: Cohort A, B and C. Participants in cohort A&B with metastatic non-small cell lung cancer (NSCLC) will receive JNJ-87704916 in combination with cetrelimab at the dose identified in Part 1. Cohort C will evaluate JNJ-87704916 treatment in combination with ongoing Standard of care (SoC) PD(L)-1 antibody therapy in frontline treatment of NSCLC.
干预措施: Standard of Care PD(L)-1 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) by Severity
时间窗: From first dose up to 100 days after last dose of study treatment (up to 5 years)
An adverse event is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. 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, 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 (DLT)
时间窗: Up to 5 years
The DLTs are specific adverse events with defined non-hematological toxicities or hematologic toxicities as per the study protocol.
次要结局
- Parts 1 and 2: Duration of Response (DOR)(Up to 5 years)
- Parts 1 and 2: Percentage of Participants With Objective Response (OR)(Up to 5 years)
- Part 2: Progression Free Survival (PFS)(From treatment initiation until disease progression or worsening or death due to any cause (up to 5 years))
- Part 2: Overall Survival (OS)(From treatment initiation until death due to any cause (up to 5 years))
- Parts 1 and 2: Number of JNJ-87704916 Genome Copies per Milliliter(Up to 5 years)
- Parts 1 and 2: Payload Concentrations of JNJ-87704916(Up to 2 years)
- Parts 1 and 2: Number of Participants with JNJ-87704916 Antibodies(Up to 2 years)
- Parts 1 and 2: Percentage of Participants With Disease Control (DC)(Up to 5 years)