A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 10
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
研究概览
简要总结
This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.
详细描述
This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce its ability to cause disease, while maintaining its ability to stimulate a potent immune response. pLADD is manufactured using patient-specific antigens and is therefore individualized to each patient.
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
- •metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
- •able to provide adequate tumor tissue from at least 1 accessible tumor site
- •completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening
- •on maintenance standard-of-care chemotherapies or on treatment holiday
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •adequate organ function
- •progression of disease at the time of Enrollment
排除标准
- •BRAF V600E mutation
- •known allergy to both penicillin and sulfa drugs
- •implanted devices that cannot be easily removed
- •immunodeficiency, immune compromised state or receiving immunosuppressive therapy
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
时间窗: Through study completion, an average of 12 months
Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0
次要结局
未报告次要终点