NL-OMON48947已完成不适用
Phase 1b multi-indication study of anetumab ravtansine (BAY 94-9343) in patients with<br>mesothelin expressing advanced or recurrent malignancies - ARCS-MT (Basket)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 9
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
- 18 至 64(—)
入选标准
- •- Availability of tumor tissue for mesothelin expression testing
- •- Histologically-confirmed, mesothelin-expressing metastatic or advanced non-metastatic disease (tumour type specific inclusion criteria)
- •- At least one measurable lesion according to either RECIST 1.1 or ITMIG modified RECIST 1.1 as applicable
- •- Adequate bone marrow, liver, renal and coagulation function
- •- LVEF * 50% of the lower limit of normal (LLN) according to local institutional ranges
- •- ECOG 0 or 1
- •- Availability of additional tumor tissue for further biomarker analysis
排除标准
- •- More than one prior anti-tubulin/microtubule agent
- •- Corneal epitheliopathy or any eye disorder that may predispose the patients to this condition
- •- Symptomatic CNS metastases and/or carcinomatous meningitis
- •- Contraindication to both CT and MRI contrast agents
- •- Active hepatitis B or C infection
- •- Pregnant or breast-feeding patients
- •- Tumor type specific exclusion criteria
研究者
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