A Pilot, Phase Ib Feasibility Study of ARGX-110 in Patients With Nasopharyngeal Carcinoma (NPC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- argenx
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Incidence and grading of AEs
研究概览
简要总结
To characterize the safety profile of ARGX-110 administered as mono- or combination therapy to patients with NPC at various stages of its natural history (adjuvant vs. metastatic).
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
metastatic/recurrent monotherapy
ARGX-110 5mg/kg once every three weeks until disease progression
干预措施: ARGX-110 (Drug)
adjuvant monotherapy
ARGX-110 5mg/kg once every three weeks for a maximum of 18 cycles
干预措施: ARGX-110 (Drug)
metastatic/recurrent combination therapy
ARGX-110 5mg/kg once every three weeks plus chemotherapy until disease progression. The choice of the chemotherapy agents is limited to: cisplatin, carboplatin, 5-fluorouracil, gemcitabine and paclitaxel.
干预措施: ARGX-110 (Drug)
结局指标
主要结局
Incidence and grading of AEs
时间窗: measured at screening, Day 1, Day 8, Day 15, Day 42, thereafter every 42 days until Day 378
Change from baseline in incidence and grading of AEs according to the Common Terminology Criteria for Adverse Event (NCI-CTCAE) Version 4.03
次要结局
- Pharmacokinetic profile of ARGX110 by Cmax(measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378)
- Biomarkers CD70 immunohistochemistry (IHC)(measured at Screening, Day 42, and thereafter every 42 days until day Day 378)
- Pharmacokinetic profile of ARGX110 by AUC(measured at Day 1 pre and post dose, Day 8, Day 15, Day 42 pre and post dose and thereafter every 42 days until Day 378)