A Phase I Dose-Escalation and Pharmacokinetic Study of TrasGEX™ in Patients With Locally Advanced or Metastatic HER-2-positive Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- optimal dose and regimen of TrasGEX™
研究概览
简要总结
This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of TrasGEX™ after intravenous administration in patients with HER-2 positive cancers. The effect of TrasGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated.
详细描述
Adult patients with advanced and/or metastatic HER2-positive cancer who were resistant to or for whom there was no standard anti-tumor therapy available at the time of enrollment and who had an estimated life expectancy of at least 3 months were eligible for participation in this study.
Patients were to receive the study drug until disease progression (clinical or radiologic), unacceptable toxicity, or any other reason leading to termination of study treatment.
Dose-escalation was performed in 3 to 6-patient cohorts.
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
- •Signed written informed consent granted prior to initiation of any study-specific procedures;
- •Male or female patients of ≥18 years of age;
- •ERBB2 (HER-2) gene amplification or ERBB2 overexpression
- •Histologically or cytologically confirmed cancer, either locally advanced or metastatic;
- •No anti-tumor therapy of proven benefit available at study enrollment;
- •Life expectancy of >=3 months;
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) <=2;
- •Male or female patients of child-producing potential must agree to use contraceptive measures or oral contraception during the study and for 28 days after the last dose of TrasGEX™;
- •Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of TrasGEX™;
排除标准
- •Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks of the first dose of TrasGEX™;
- •Major surgery within four weeks of the first dose of TrasGEX™;
- •Newly diagnosed brain metastases, metastases that have been documented to be stable for <3 months, or metastases for which systemic corticosteroids are required;
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition as TrasGEX™;
- •History of myocardial infarction within 12 months of the administration of the first dose of TrasGEX™;
- •History of congestive heart failure defined as Class II to IV per New York Heart Association classification within 12 months of the administration of the first dose of TrasGEX™;
- •Left ventricular ejection fraction <50%;
- •Previous malignancy other than the current diagnosis within 5 years of the first dose of TrasGEX™;
- •Pregnancy or lactation; and
- •Concurrent uncontrolled significant illness
研究组 & 干预措施
TrasGEX
A total of 37 patients with advanced HER2-positive carcinomas and progressive disease.
干预措施: TrasGEX™ (Drug)
结局指标
主要结局
optimal dose and regimen of TrasGEX™
时间窗: up to at least 8 weeks after the first TrasGEX™ administration
The primary objective of this first-in-man study is to determine the optimal dose and regimen of TrasGEX™ in patients with locally advanced or metastatic human epidermal growth factor receptor-2 (HER-2)-positive cancer. The recommended phase II dose needs to have an acceptable safety profile and provides evidence for efficacy based on clinical observations or the pharmacokinetic profile.
次要结局
- To determine preliminary evidence of activity(approx. every 8 weeks)
- To assess the pharmacokinetic (PK) profile of TrasGEX™ (part II)(prior to 1st infusion until the end of 5th infusion)
- To assess the pharmacokinetic (PK) profile of TrasGEX™ (part I)(prior to 1st infusion until the end of 5th infusion)
- safety and tolerability of TrasGEX™(until 4 weeks after the last treatment with TrasGEX™)