A Phase 1 Study of FluBHPVE6E7 Immunotherapy in Patients With HPV16- Associated Oropharyngeal Squamous Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Frequency and severity of adverse events (AEs)
研究概览
简要总结
A clinical study of an immunotherapy in patients with head or neck cancers associated with the HPV16 virus
详细描述
Squamous cell carcinomas of the head and neck (HNSCC) rank as the sixth most common cancer globally, with approximately 575,000 new cases diagnosed each year. In recent years, there has been a rising incidence in younger patients who have limited exposure to traditional risk factors such as smoking and alcohol. This increase is closely associated with HPV infection, particularly HPV-16, which is strongly linked to oropharyngeal cancer. Treatment for HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) is highly individualized, depending on the disease stage, patient comorbidities, and personal preferences. In this phase 1 study, patients with HPV-16-associated OPSCC are being treated with the immunotherapeutic delNS-vector expressing the HPV-16 oncogenes E6 and E7, administered both intratumorally and intramuscularly.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intervention
FlubHPVE6E7
干预措施: FluBHPVE6E7 (Biological)
结局指标
主要结局
Frequency and severity of adverse events (AEs)
时间窗: 7 days
To assess the severity of the adverse event is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.
次要结局
- Intralesional T-cell infiltration(24 weeks)
- Biodistribution(24 weeks)
- Virus recovery in oropharyngeal secretion samples(7 days)
- Virus recovery in saliva(7 days)
- Frequency and severity of adverse events (AEs)(24 weeks)
- Disease-free survival (DFS)(60 months)
- Overall survival (OS)(60 months)
- Induction of HPV-specific T-cell response following FluBHPVE6E7 administration(24 weeks)
- Hemagglutination Inhibition (HAI) Geometric Mean Titers (GMTs) following FluBHPVE6E7 administration(24 weeks)