NCT01911936已完成1 期
A Phase I Study of LJM716 in Japanese Patients With Advanced Solid Tumors
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
- 12
- 试验地点
- 1
- 主要终点
- Incidence of dose-limiting toxicities (DLTs) in the dose escalation part
研究概览
简要总结
This study will evaluate safety and tolerability to estimate the MTDand/or recommended dose.
详细描述
This is a phase I, open-label, dose-escalation study to establish the MTD and/or RDE of LJM716 as single agent in Japanese patients that have advanced solid tumors. The study consists of a dose escalation part and a dose expansion part.
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
- •Patients with the following indications:
- •i) (Dose escalation part only): HER2 overexpressing locally advanced/ metastatic breast cancer or gastric cancer for which no effective treatment option exists:
- •For breast cancer: documented 3+ by immunohistochemistry, or amplification by in situ hybridization
- •For gastric cancer (including GE junction tumors): documented 3+ by immunohistochemistry, or 2+ by immunohistochemistry and amplification by in situ hybridization OR, ii) (Dose escalation part only): Recurrent or metastatic SCCHN regardless of HER2 status for which no effective treatment option exists OR, iii) Recurrent or metastatic ESCC regardless of HER2 status for which no effective treatment option exists
- •ECOG Performance Status of 0-2
- •Must have recovered from the adverse effects of any prior surgery, radiotherapy or other antineoplastic therapy. Alopecia and CTCAE Grade 1 peripheral neuropathy is acceptable.
- •Willingness and ability to comply with all study procedures
- •Written informed consent obtained prior to any screening procedures
- •During dose expansion part of the study, patients must have at least one measurable lesion as defined by RECIST v1.1 criteria
排除标准
- 未提供
研究组 & 干预措施
LJM716
Experimental
干预措施: LM716 (Drug)
结局指标
主要结局
Incidence of dose-limiting toxicities (DLTs) in the dose escalation part
时间窗: First cycle (28 days)
次要结局
- Frequency and severity of adverse events, number of and reasons for(from informed consent till 30 days after end of treatment)
- LJM716 serum concentration-time- profile and estimated PK(up to 10 cycle (1 cycle = 28 days))
- Tumor response according to RECIST 1.1(every 2 months until end of treatment up to 2 years)
- Incidence of antibodies against LJM716(up to 10 cycle ( 1cycle = 28 days))
研究者
研究点 (1)
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