BMS-191352 is a fusion protein immunotoxin constructed from the variable regions of the monoclonal antibody BR96 and the toxin moiety of Pseudomonas exotoxin (PE). This agent binds to the Lewis-y antigen which is expressed on the surface membrane of cells in many tumors. After binding to the antigen, the agent is internalized, where upon it acts as a potent inhibitor of protein synthesis, which allows it to kill cells. BMS-191352 has demonstrated excellent activity in animal tumor models. The primary purpose of this Phase I study is to determine the maximum tolerated dose (MTD) of BMS-191352. The safety of BMS-191352 administered on days 1, 4, 8, and 11 and a 28-day course as a bolus IV infusion, will be defined. Groups of three to six patients will be tested at each dose level of BMS-191352 for injection. It is estimated that 30-50 patients will be necessary to determine the MTD. Patient accrual is expected to require 12 to 18 months.
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