A total of 40 patients with metastatic cancer expressing the Lewis y antigen have been treated on the phase I trial of the doxorubicin containing monoclonal immunoconjugate comprising of the anti-Lewis y antibody and doxorubicin. In vitro this immunoconjugate induces tumor repression as well as complete tumor irradication in Lewis y expressing tumors in nude mice. To date, toxicity has consisted of exudative gastritis involving the gastric body and extending to the duodenum at higher doses. Toxicity is reversible and appears to be slightly ameliorated by pre-therapy with steroids. Further toxicity has also included nausea and vomiting which is transient yet generally unresponsive to conventional anti-emetic therapy. A phase II dose of 700mg/m2 of BR96-Dox has been established.
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