IMF-001 Phase 1 Study With Refractory Esophageal Tumor
IMF-001 Phase 1 Study With Refractory Esophageal Tumor
The purpose of this study is to determine the biological recommended dose of IMF-001.
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.
Inclusion Criteria:
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:
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
Exclusion Criteria: