NCT00747734已完成1 期
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Incidence and nature of dose-limiting toxicities (DLTs)
研究概览
简要总结
This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.
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
- •Age ≥ 18 years
- •Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen
- •Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease)
排除标准
- •Inadequate hematologic or organ function
- •Anti-cancer therapy within 4 weeks prior to initiation of study treatment
- •Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders
- •Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava
- •Active infection or autoimmune disease
- •Known human immunodeficiency virus (HIV) infection
- •Pregnancy or breast feeding
结局指标
主要结局
Incidence and nature of dose-limiting toxicities (DLTs)
时间窗: Length of study
次要结局
- Total exposure (AUC)(Length of study)
- Maximum and minimum serum concentrations(Length of study)
- Clearance(Length of study)
- Volume of distribution(Length of study)
研究者
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