JPRN-jRCT2080224876已完成1 期
An open-label Phase 1b/2 study of E7389 liposomal formulation plus Nivolumab in subjects with solid tumor
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
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
- •1. Phase 1b part only: subjects with advanced, nonresectable, or recurrent solid tumor for which no alternative standard therapy or no effective therapy exists (subjects who will be the candidate of treatment by nivolumab monotherapy as standard therapy is acceptable).
- •2. Phase 2 part only: nonresectable GC, EGC or SCLC subjects with confirmed diagnosis who showed disease progression by investigator's assessment during or after 1st line chemotherapy (2nd line chemotherapy for GC) and did not receive any other systemic chemotherapy to advanced/recurrent disease.
- •3. Subjects who have accessible tumors for biopsy and agree with tumor biopsy for pre and post treatment of study drug.
- •4. Life expectancy of >=12 weeks
- •5. ECOG-PS 0-1
- •6. Phase 2 part only: At least one measurable lesion based on RECIST 1.1 (Lesions that have had radiotherapy or loco-regional therapies must show evidence of progressive disease to be deemed a measurable lesion).
排除标准
- •1. Diagnosed with meningeal carcinomatosis.
- •2. Subjects with brain or subdural metastases or invasion.
- •3. Subjects with any active, known, or suspected autoimmune disease.
研究者
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A phase II open label single-arm study of E7389 in patients with locally advanced or metastatic breast cancer, previously treated with anthracycline, taxane, and capecitabine therapy, refractory to the last prior therapy for their disease. - E7389-G000-211ocally advanced or metastatic breast cancerEUCTR2005-003656-35-ESEisai Limited300