A phase I radioimmunolocalization trial of humanized monoclonal antibody huA33 in patients with gastric carcinoma

Abstract

In order to determine the in vivo characteristics of huA33, an open label dose escalation biopsy‐based phase I clinical trial and radioimmunolocalization study were conducted with a complement determinant region‐grafted humanized monoclonal antibody against the A33 antigen in patients with gastric carcinoma. Thirteen patients were entered onto one of four dose levels (1.0, 2.0, 5.0 or 10.0 mg/m2). Patients with locally advanced (UICC‐TNM [International Union Against Cancer–tumor, node, metastasis] stage over 2 but resectable at clinical diagnosis) gastric carcinoma received a single infusion of 131I‐huA33 1 week prior to surgery. Adverse events were monitored, and imaging studies with gamma ..