JPRN-jRCT2011210017招募中2 期
Phase II, multicenter, open-label study of Trastuzumab derxtecan in patients with HER2-expressing recurrent and or metastatic salivary gland carcinoma
Hirotoshi Akita0 个研究点目标入组 52 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •20 years and over at the time of written informed consent
- •Histologically confirmed recurrent and or metastatic salivary gland carcinoma
- •No indication for curative treatment
- •Tumor tissue or undryed glass specimen is available
- •IHC 3 plus IHC 2 plus IHC 1 plus and or ISH plus
- •Patient with measurable lesion by RECIST version 1.1
- •ECOG performance status of 0 or 1
- •Adequate organ function
排除标准
- •History and complication of myocardial infarction or congestive heart failure
- •Prolonged QT interval
- •Complication of Interstitial lung disease
- •Active central nervous system metastasis
- •Other active malignancies
- •Prior treatment with ADC of Exatecan derivative Topoisomerase I inhibitor
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