Phase 1 Study of Intratumoral Administration of JNJ-1761981 ER, an Extended Release Chemotherapy, in Participants With Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 4
- 主要终点
- Part 1: Number of Participants with Adverse Events (AE) by Severity
研究概览
简要总结
The purpose of Part 1 of this study is to determine a safe, tolerable, and feasible recommended total dose of intratumorally administered JNJ-1761981. The purpose of Part 2 of this study is to identify the optimal volumetric dose of JNJ-1761981 for the treatment of tumor lesions.
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
- •Part 1: Individuals with a diagnosis of locally advanced or metastatic disease (solid tumors except tumors of the central nervous system [CNS]) who have previously received available standard therapy and progressed, or cannot tolerate standard therapy, or for whom there is no standard of care per regional guidelines
- •Part 2 Cohort A: Individuals with histologically or cytologically confirmed metastatic tumors of adenocarcinoma or squamous cell carcinoma histology, for which any platinum-based systemic regimen is considered a standard of care (per national comprehensive cancer network [NCCN] guidelines) and whose disease has progressed after standard therapy
- •Eastern cooperative oncology group performance status (ECOG) performance status of Grade 0 or 1
- •Part 2 Cohort A participants planned to receive optional cetrelimab (participants not meeting this criterion may still be enrolled in the study but cannot receive cetrelimab): Thyroid function laboratory values within normal range except for participants on thyroid hormone replacement therapy
- •A participant of childbearing potential must practice at least 2 highly effective methods of contraception throughout the study and through 14 months (for women) and 11 months (for men) after the last dose of JNJ-1761981 or 5 months after the last dose of cetrelimab or other anti-PD(L)1 treatment, whichever is later
排除标准
- •Active symptomatic disease involvement of the central nervous system
- •Prior or concurrent second malignancy (other than the disease under study) that due to natural history or treatment is likely to interfere with any study endpoints of safety or the antitumor activity of the study treatment(s)
- •Active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures
- •Known allergies, hypersensitivity, or intolerance to JNJ-1761981 or its excipients
- •Lesions invading or adjacent to major blood vessels or other critical structures (for example, airways) not suitable for injection
研究组 & 干预措施
Part 2: Dose Expansion
Participants in Cohort A will receive JNJ-1761981 at specified volumetric doses. Participants who receive more than 1 dose of JNJ-1761981 may receive optional systemic therapy with cetrelimab at the discretion of the treating physician.
干预措施: Cetrelimab (Drug)
Part 1: Dose Escalation
Participants will receive JNJ-1761981 intratumorally to determine a safe and tolerable total JNJ-1761981 dose.
干预措施: JNJ-1761981 (Drug)
Part 2: Dose Expansion
Participants in Cohort A will receive JNJ-1761981 at specified volumetric doses. Participants who receive more than 1 dose of JNJ-1761981 may receive optional systemic therapy with cetrelimab at the discretion of the treating physician.
干预措施: JNJ-1761981 (Drug)
结局指标
主要结局
Part 1: Number of Participants with Adverse Events (AE) by Severity
时间窗: Up to approximately 2 years 10 months
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Severity of AEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version (v) 5.0. by using standard grades as follows: Grade 1: Mild; asymptomatic or mild symptoms; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; Grade 3: Severe but not immediately life threatening; hospitalization or prolongation of hospitalization indicated; Grade 4: Life-threatening consequences; and Grade 5: Death related to AE.
Part 1: Number of Participants with Dose-Limiting Toxicities (DLTs)
时间窗: Up to 28 days
High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.
Part 1: Number of Participants with AEs by Severity Related to Delivery Device and/or Procedure
时间窗: Up to approximately 2 years 10 months
An AE is any untoward medical occurrence in a participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the treatment. Participants with AEs related to delivery device and/or procedure will be reported.
Part 1: Number of Participants who Received Planned Total Dose per Level
时间窗: Up to approximately 28 days
Number of participants who received planned total dose per level will be reported.
Part 2: Administered Tumor Response Rate
时间窗: Up to approximately 2 years 10 months
Administered tumor response rate is defined as the percentage of JNJ-1761981 administered lesions that achieve complete response (CR) or partial response (PR).
次要结局
- Parts 1 and 2: Plasma Concentration of Free and Total Platinum(Up to approximately 2 years 10 months)
- Part 1: Administered Tumor Response Rate(Up to approximately 2 years 10 months)
- Parts 1 and 2: Administered Tumor Duration of Response(Up to approximately 2 years 10 months)
- Parts 1 and 2: Objective Response Rate (ORR)(Up to approximately 2 years 10 months)
- Parts 1 and 2: Disease Control Rate (DCR)(Up to approximately 2 years 10 months)
- Parts 1 and 2: Duration of Response (DOR)(Up to approximately 2 years 10 months)
- Part 2: Number of Participants with Adverse Events (AE) by Severity(Up to approximately 2 years 10 months)
- Part 2: Number of Participants with AE by Severity Related to Delivery Device and/or Procedure(Up to approximately 2 years 10 months)
- Part 2: Number of Participants who Received Planned Intratumoral Volumetric Dose(Up to approximately 2 years 10 months)