NCT01271972已完成1 期
A Phase 1 Study of REGN910 Administered Every 2 Weeks in Patients With Advanced Solid Malignancies
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
- 53
- 主要终点
- Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies
研究概览
简要总结
This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) administered IV every 2 weeks.
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
- •Confirmed diagnosis of advanced solid malignancy.
- •ECOG performance status 0 - 1
- •Adequate hepatic, renal and bone marrow function
- •At least 3 weeks since last dose of chemotherapy, hormonal therapy or radiotherapy
- •At least 6 weeks since last dose of bevacizumab
- •At least 4 weeks since last surgery
- •At least 4 weeks since last dose of investigational treatment
排除标准
- •Patients with brain metastases, spinal cord compression, carcinomatous meningitis, or other evidence of central nervous system involvement
- •Patients with serious non healing wound or acute ulcer
- •Either systolic blood pressure >150 mm Hg or diastolic blood pressure >95 mm Hg
- •Patients with medical history of myocardial infarction, unstable angina pectoris, coronary/ peripheral artery bypass graft, congestive heart failure or ventricular arrhythmia
- •Patients with deep vein thrombosis or pulmonary embolism within last 6 months
研究组 & 干预措施
Expansion Cohort 1
Experimental
Dose 4
干预措施: nesvacumab (REGN910/ SAR307746) (Drug)
Cohort 3
Experimental
Dose 3
干预措施: nesvacumab (REGN910/ SAR307746) (Drug)
Expansion Cohort 2
Experimental
Dose 5
干预措施: nesvacumab (REGN910/ SAR307746) (Drug)
Cohort 5
Experimental
Dose 5
干预措施: nesvacumab (REGN910/ SAR307746) (Drug)
Cohort 4
Experimental
Dose 4
干预措施: nesvacumab (REGN910/ SAR307746) (Drug)
Cohort 2
Experimental
Dose 2
干预措施: nesvacumab (REGN910/ SAR307746) (Drug)
Cohort 1
Experimental
Dose 1
干预措施: nesvacumab (REGN910/ SAR307746) (Drug)
结局指标
主要结局
Determine the maximum tolerable dose or recommended phase 2 dose of nesvacumab (REGN910/ SAR307746) in patients with advanced solid malignancies
时间窗: 28 days
次要结局
- PK/PD profile(28 days)
- Immunogenicity(28 days)
- Correlative biomarkers(28 days)
- Anti-tumor activity(28 days)
研究者
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