NCT01603979已完成1 期
A Phase 1 Open-label, Multiple Dose, Dose Escalation Study of Monoclonal Antibody AV-203 Administered in Subjects With Metastatic or Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 4
- 主要终点
- Incidence of AEs, SAEs and Dose-limiting Toxicities (DLTs)
研究概览
简要总结
This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the RP2D for safety 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
- •≥ 18 years of age
- •Histologically and/or cytologically confirmed primary diagnosis
- •Metastatic or advanced solid tumor, that has recurred or progressed following standard therapies, or for which no standard therapy exists
- •Must have available tumor tissue or be willing to undergo biopsy prior to enrollment
- •Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- •Blood Chemistry and Hematology results within defined limits
排除标准
- •History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent
- •Current central nervous system (CNS) or leptomeningeal metastases, or history of CNS or leptomeningeal metastases.
- •Significant conduction disturbance, history of a severe arrhythmia, or history of a familial arrhythmia
- •Significant cardiovascular disease
- •Significant thromboembolic or vascular disorders within prior 3 months
- •Any other medical condition or psychiatric condition that, in the opinion of the Investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results
- •Known history of positive results for hepatitis C, hepatitis B, or human immunodeficiency virus.
- •For female subjects, pregnancy or lactation.
结局指标
主要结局
Incidence of AEs, SAEs and Dose-limiting Toxicities (DLTs)
时间窗: Ongoing throughout study. DLTs evaluated for first cycle of therapy. 1 cycle = 28 days
次要结局
- Maximum Plasma Concentration (Cmax) of AV-203(pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose)
- Time to Cmax (Tmax) of AV-203(pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose)
- Area Under Plasma Concentration (AUC) of AV-203(pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose)
- Terminal phase half-life (t1/2) of AV-203(pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose)
- Clearance (Cl) of AV-203(pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose)
- Objective Response Rate (ORR)(Within 28 days of first dose and every 8 weeks while on study)
- Volume of Distribution (Vd) of AV-203(pre-dose, 5 min, 15 min, 7 hr, 24 hr, 168 hr post-dose)
- Disease Control Rate (DCR)(Within 28 days of first dose and every 8 weeks while on study)
- Duration of Response (DOR)(Within 28 days of first dose and every 8 weeks while on study)
- Time to Progression (TTP)(Within 28 days of first dose and every 8 weeks while on study)
研究者
研究点 (4)
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