IMF-001 Phase 1 Study With Refractory Esophageal Tumor
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
First 12 weeks (during the first 6 injections)
Yes
Daiju Ichimaru, BSc
Study Director
ImmunoFrontier, Inc.
Japan: Pharmaceuticals and Medical Devices Agency
IMF001J
NCT01003808
November 2009
December 2012
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