NCT02576548已完成1 期
A Phase 1/2 Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Immunogencity, and Antitumor Activity of MEDI4276 in Subjects With Select HER2-expressing Advanced Solid Tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 6
- 主要终点
- Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs) and dose-limiting (DLTs).
研究概览
简要总结
This research study is designed to evaluate an experimental drug, MEDI4276, in treating breast and stomach (gastric) cancer.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Histologically or cytologically documented unresectable, locally advanced or metastatic breast cancer or gastric cancer refractory to standard therapy.
- •For subjects with breast cancer:
- •Prior treatment with trastuzumab, pertuzumab, and T-DM1, either alone or in combination, is required.
- •Subjects with a primary tumor that is hormone (estrogen, progesterone, or both) receptor-positive or receptor-negative are eligible.
- •Prior hormone therapy is allowed, but last dose must be at least 14 days prior to first dose of MEDI
- •For subjects with gastric cancer:
- •Prior treatment with a trastuzumab containing chemotherapy regimen is required.
- •HER2 Positive disease documented as FISH-positive and/or 3+ by IHC on previously collected tumor tissue.
- •At least one lesion measurable by RECIST Version 1.1.
排除标准
- •Receipt of any conventional or investigational anticancer treatment within 28 days prior to the first dose of MEDI
- •History of exposure to the following cumulative doses of anthracyclines:
- •Doxorubicin or liposomal doxorubicin >350 mg/m².
- •Epirubicin >530 mg/m².
- •Mitoxantrone >90 mg/m² and idarubicin > 70 mg/m².
- •If another anthracycline or more than 1 anthracycline has been used, then the cumulative dose must not exceed the equivalent of 350 mg/m² of doxorubicin.
- •Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery or other therapy to control symptoms from brain metastases within 2 months prior to first dose of MEDI4276.
结局指标
主要结局
Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs) and dose-limiting (DLTs).
时间窗: From Time of informed consent through 90 days after last dose of MEDI4276
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs. The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
次要结局
- Overall survival (OS)(Estimated to be from time of informed consent up to 3 years)
- Peak Plasma Concentration (Cmax)(From first dose of MEDI4276 thorugh to 30 days after last dose of investigational product)
- Objective Response Rate (ORR)(Time from Informed Consent up to 3 years)
- Progression-free survival (PFS)(Estimated to be from time of informed consent up to 3 years)
- Area under the plasma concentration versus time curve (AUC)(From first dose of MEDI4276 through to 30 days after the last dose of investigational product)
研究者
研究点 (6)
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