A Phase I, Open-label, Dose-Finding Study to Assess the Safety and Tolerability of U3-1287 (AMG 888), a Human Monoclonal Antibody Targeting HER3 in Patients With Advanced Solid Tumors.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors
研究概览
简要总结
This is a Phase 1 clinical study to investigate the safety, pharmacokinetics, and pharmacodynamics of U3-1287 (AMG 888), a fully human monoclonal antibody targeting the HER3 receptor, in patients with advanced solid tumors. Eligible patients will have disease that is refractory or resistant to standard treatments or for which no standard therapy exists. The study will be conducted in two parts; a dose escalation (Part 1) and a dose expansion (Part 2). The hypothesis for this study is that U3-1287 (AMG888) will be safe and well tolerated in patients with advanced solid tumors and will show initial evidence of anti-tumor activity.
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
- •Pathologically or cytologically documented advanced solid tumor that is refractory to standard treatment, for which no standard therapy is available, or the patient refuses standard therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Men or women at least 18 years of age
- •Adequate hematologic, cardiac, renal, hepatic, metabolic, and coagulation function
排除标准
- •Presence of untreated or symptomatic brain metastasis.
- •Presence of ascites or pleural effusion requiring chronic medical intervention.
- •Uncontrolled hypertension
- •Concurrent or previous (within 1 week of study day 1) anticoagulation therapy, except low-dose warfarin (≤ 2 mg/day) or low dose,low molecular weight heparin for prophylaxis against central venous catheter thrombosis.
- •Recent major surgical procedure or not yet recovered from major surgery
- •Recent participation in clinical drug trials.
- •Participation in other investigational procedures.
- •Unresolved toxicities from prior anti-cancer therapy
- •Patient who is pregnant (e.g. positive human choriogonadotropin [HCG] test) or nursing.
研究组 & 干预措施
1
干预措施: U3-1287 (AMG888) (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of U3-1287 (AMG888) in patients with advanced solid tumors
时间窗: Lenth of study
To evaluate maximum tolerated dose (MTD) of U3-1287(AMG888) when administered intravenously to patients with advanced solid tumors
时间窗: Lenth of study
次要结局
- Pharmacokinetic Parameters(Length of study)
- Pharmacodynamic Parameters(Length of study)
- Human anti-human antibody profile for U3-1287(AMG888)(Length of study)