A Phase 1, First-in-human, Single-arm, Multi-center, Open-label, Repeated-Dose, Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MP0274 in Patients With Advanced HER2-positive Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Incidence and severity of adverse events
研究概览
简要总结
This study is investigating a new experimental therapy, MP0274, a DARPin® drug candidate targeting HER2. Preclinical studies suggest that MP0274 may provide additional benefit for the treatment of HER2-positive cancers. This is the first study of MP0274 in humans and its main purpose is to test its safety and tolerability in patients with HER2-positive cancer. This study will also examine the blood levels of MP0274 at several escalating dose levels and a recommended dose for further development will be determined. The recommended dose will be tested in a second part of the study to confirm safety and to further assess the preliminary biologic and anti-tumor activity
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MP0274
干预措施: MP0274 (Drug)
结局指标
主要结局
Incidence and severity of adverse events
时间窗: from first infusion to end-of-study visit, up to 12 months
Number and grading according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
次要结局
- Pharmacokinetics of MP0274(from first infusion to end-of-study visit, up to 12 months)
- Preliminary assessment of anti-tumor activity of MP0274(from first infusion to end-of-study visit, up to 12 months)
- Incidence of anti-drug-antibodies(from first infusion to end-of-study visit, up to 12 months)