Phase 1 Dose Escalation Trial of Intra-Tumoral Injection of Sodium Iodide Simporter (NIS) Measles Virus (Edmonston Strain) in Combination With Atezolizumab in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Vyriad, Inc.
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab
研究概览
简要总结
This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and metastatic NSCLC.
详细描述
Phase 1, dose escalation study of the combination of intra-tumoral MV-NIS and systemic atezolizumab in patients with recurrent and metastatic NSCLC. After the dose escalation phase of the trial, a dose expansion cohort was planned to further investigate safety, clinical and immune responses at the MTD. A standard 3+3 design was to be used for the dose escalation part of the study. Starting at dose level 1, three patients were to be treated per dose level. MV-NIS was to be administered once intra-tumorally (IT) on Day 1 of treatment in 3 escalating dose cohorts, starting at dose level 1 x 10e8
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS.
- •Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or
- •Ability to provide informed consent.
- •Adequate hematological, liver and kidney function.
- •Must be willing to implement contraception throughout study and for the 8 weeks following last study drug administration.
排除标准
- •Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration. Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to registration
- •Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation).
- •Pregnant women.
- •Nursing women.
- •Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment.
- •Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
- •History of organ transplantation.
结局指标
主要结局
Maximum Tolerated Dose (MTD) of MV-NIS in Combination With Atezolizumab
时间窗: 28 days after MV-NIS administration for each dose cohort
To determine the maximum tolerated dose (MTD) of the intra-tumoral administration of an Edmonston strain MV genetically engineered to produce NIS (MV-NIS), in combination with the PD-L1 inhibitor atezolizumab
次要结局
未报告次要终点