A Phase 1 Trial of TGN-S11 in Patients With Human Papillomavirus (HPV)-Associated Relapsed, Resistant or Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Maximum Tolerated Dose
研究概览
简要总结
This is an open-label, non-randomized, Phase I, dose escalation/dose expansion study in cohorts of patients with relapsed, resistant, or metastatic HPV-associated cancers. The Expansion Phase will begin in parallel one dose level lower than the highest dose deemed safe in the Dose Escalation in combination with a PD-1 checkpoint blockade.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Prior histologically confirmed HPV-associated squamous cell carcinoma, which is relapsed, resistant, or metastatic
- •Life expectancy of at least 3 months
- •Dose Escalation Phase: patients who have experienced disease progression on Standard of Care Therapies
排除标准
- •Active CNS metastases
- •Have any history of seizure disorder or are taking prophylactic seizure medication
- •Have an active viral, bacterial, or fungal infection
研究组 & 干预措施
Dose Escalation
To determine the MTD in patients with HPV-associated cancers
干预措施: TGN-S11 (Drug)
Dose Expansion
Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade.
干预措施: TGN-S11 (Drug)
Dose Expansion
Dose Expansion Phase, in parallel one dose level lower than the highest dose deemed safe in Dose escalation with a PD-1 checkpoint blockade.
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Maximum Tolerated Dose
时间窗: 12 months
To determine the maximum tolerated dose (MTD) of TGN-S11 in patients with human papillomavirus (HPV)-associated relapsed, resistant, or metastatic cancer.
次要结局
- PK Parameters to determine the single dose(30 days)
- Steady state pharmacokinetics (PK) of TGN-S11(30 days)