A Phase I, Open Label, Dose Escalation Study of the Safety and Pharmacology of MetMAb (PRO143966), a Monovalent Antagonist Antibody to the Receptor C-Met, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Safety and tolerability of MetMAb alone or in combination with bevacizumab will be assessed (frequency and nature of dose-limiting toxicities; nature, severity, and relatedness of adverse events; changes in vital signs and clinical laboratory parameters)
研究概览
简要总结
This is a Phase I, open label, dose-escalation study of MetMAb administered by intravenous (IV) infusion in patients with advanced solid malignancies that are refractory to or for which there is no standard of care. The study consists of a dose-escalation stage, an expansion stage testing MetMAb at the recommended Phase II dose (RP2D), and a dose-escalation stage testing the combination of MetMAb, at two different doses with bevacizumab at a recommended dose.
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
- •Histologic documentation of incurable, locally advanced, or metastatic solid malignancy that has failed to respond to at least one prior regimen or for which there is no standard therapy
- •Disease that is measurable or evaluable by Response Evaluation Criteria In Solid Tumors (RECIST)
- •Life expectancy ≥12 weeks
排除标准
- •Less than 4 weeks since the last anti-tumor therapy
- •Patients receiving erythropoietin products
- •Active infection requiring antibiotics
- •Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs
- •Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- •Clinically important history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
- •Known human immunodeficiency virus infection
- •Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
研究组 & 干预措施
Stage I
干预措施: MetMAb (Drug)
Stage II
干预措施: MetMAb (Drug)
Stage III
干预措施: bevacizumab (Drug)
Stage III
干预措施: MetMAb (Drug)
结局指标
主要结局
Safety and tolerability of MetMAb alone or in combination with bevacizumab will be assessed (frequency and nature of dose-limiting toxicities; nature, severity, and relatedness of adverse events; changes in vital signs and clinical laboratory parameters)
时间窗: Length of study
次要结局
- Objective response, defined as a complete or partial response confirmed ≥4 weeks after initial documentation(Length of study)
- Duration of objective response(Length of study)
- Progression-free survival(Length of study)