NCT02375958已完成1 期
A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Incidence rate of dose limiting toxicities
研究概览
简要总结
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Head and Neck Cancer
Experimental
干预措施: PCA062 (Drug)
Esophageal Cancer
Experimental
干预措施: PCA062 (Drug)
Triple Negative Breast Cancer
Experimental
干预措施: PCA062 (Drug)
结局指标
主要结局
Incidence rate of dose limiting toxicities
时间窗: 28 days
次要结局
- Incidence and severity of serious/adverse events(Duration of study (each treatment cycle = 14 days))
- Pharmacokinetic parameter Cmax(84 days)
- Overall response rate(Duration of study (each treatment cycle = 14 days))
- Duration of response(Duration of study (each treatment cycle = 14 days))
- Presence of PCA062 anti-bodies(84 days)
- Disease control rate(18 months)
- Progression free survival(18 months)
- Best overall response(Duration of study (each treatment cycle = 14 days))
- Pharmacokinetic paramater Tmax(84 days)
研究者
研究点 (1)
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