Abstract
2624 Background: IGN311 is a humanized monoclonal antibody (mab) binding to Lewis Y, a blood group-related carbohydrate determinant that has been found to be associated with 60–90% of human epithelial carcinomas (ca) incl. breast, colon, gastric and lung cancers. IGN311 is a fully humanized IgG1 variant 1 of the parent murine IgG3 mab ABL 364. Methods: Open-label, single treatment arm, uncontrolled dose escalating phase I study, enrolling 10 evaluable subjects. 7 Patients had colorectal cancer, 1 gastric cancer, 1 pancreatic cancer, 1 breast cancer. Pts: >18y, biopsy-proven ca that has failed or is considered refractory to standard agents, KPS >70 at baseline, an estimated life expectancy >4 months. No chemotherapy for at least 4 weeks prior to start of trial. Treatment: 50 or 100 or 200 mg IGN311 given by iv infusion on day (d) 1 and 15; final visit on d43. Primary Objective: Safety, tolerability, immunogenicity (human anti human antibodies, HAMA). Secondary Objectives: serum half-life, ex-vivo CDC activ...
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