IMF-001 Phase 1 Study With Refractory Esophageal Tumor
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- To evaluate the maximum tolerated dose, dose-limiting toxicities, type/frequency/degree of adverse events and NY-ESO-1 antigen-specific immune response of IMF-001 alone in patients with esophageal cancer.
研究概览
简要总结
The purpose of this study is to determine the biological recommended dose of IMF-001.
详细描述
The prognosis of esophageal cancer is improved with the improvement of surgery, chemotherapy and radiation therapy. However, there are no standard therapies established for recurrent esophageal cancer. NY-ESO-1 antigen is expressed in 33% of patients. NY-ESO-1 protein is applicable without limitation by HLA types, and injected as a complex with cholesteryl pullulan (CHP), forming nano-particles (IMF-001), it can activate both CD4+ and CD8+ T cells. In this phase 1 study, the safety and the biological recommended dose will be determined.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radically unresectable stage III/IV esophageal tumors that have failed the standard treatment (including chemotherapy and radiotherapy), recurrent metastasis after radical surgery and not responding to the standard treatments, or recurrent metastasis after radiotherapy before/after radical surgery.
- •Primary esophageal tumors confirmed by pathological diagnosis
- •Tumor cells expressing NY-ESO-1 antigen (by tissue-immunostaining method or quantitative RT-PCR method)
- •Performance status (PS) of 0, 1 or 2 (ECOG Scale)
- •Life expectancy >/= 4 months
- •No serious disorders with major organs (bone marrow, heart, lung, liver and kidney) and meets the following criteria:
- •WBC count >/= 2.0 x 10 9/L
- •Hemoglobin >/=8.0g/dL
- •Platelet count >/=75 x 10 9/L
- •Serum total bilirubin: </=1.5 x ULN (3 x ULN if with liver mets)
- •AST and ALT: </=2.5 x ULN (5x ULN if with liver mets)
- •Serum creatinine: </=1.5x ULN
- •Agree to use birth control including condoms from the time of obtaining the consent to 6 months after the final administration of the study drug [except females after menopause (1 year or more after the last menstruation and females/males after an operation for sterilization)]
- •Given written informed consent
排除标准
- •HIV antibody positive
- •Double cancer
- •History of autoimmune disease
- •History of severe anaphylaxis
- •Active metastatic disease in the central nervous system (CNS) Within 4 weeks after treatment with an anti-tumor agent, systemically administered adrenocorticosteroids, immune suppressants or immune enhancers
- •Pregnant or lactating
- •Any other inadequacy for this study
研究组 & 干预措施
IMF-001
100 or 200 mcg, subcutaneously every 2 weeks. Number of Injections: 6 times. (The treatment may be continued if it is beneficial to the subject).
干预措施: IMF-001 (Biological)
结局指标
主要结局
To evaluate the maximum tolerated dose, dose-limiting toxicities, type/frequency/degree of adverse events and NY-ESO-1 antigen-specific immune response of IMF-001 alone in patients with esophageal cancer.
时间窗: First 12 weeks (during the first 6 injections)
次要结局
- To evaluate clinical activity (tumor response and time to progression).(Up to 2 years, or until progression of PS or no positive immune response from IMF-001.)