Journal article

A phase I trial of humanized monoclonal antibody A33 in patients with colorectal carcinoma: Biodistribution, pharmacokinetics, and quantitative tumor uptake

AM Scott, FT Lee, R Jones, W Hopkins, D MacGregor, JS Cebon, A Hannah, G Chong, P U, A Papenfuss, A Rigopoulos, S Sturrock, R Murphy, V Wirth, C Murone, FE Smyth, S Knight, S Welt, G Ritter, E Richards Show all

CLINICAL CANCER RESEARCH | AMER ASSOC CANCER RESEARCH | Published : 2005

Abstract

PURPOSE: To determine the in vivo characteristics of huA33, a CDR-grafted humanized antibody against the A33 antigen, we have conducted an open-label, dose escalation, biopsy-based phase I trial of huA33 in patients with colorectal carcinoma. EXPERIMENTAL DESIGN: Patients with colorectal carcinoma were infused with [131I]huA33 (400 MBq: 10 mCi) and [125I]huA33 (40 MBq: 1 mCi) 1 week before surgery. There were four huA33 dose levels (0.25, 1.0, 5.0, and 10 mg/m2). Adverse events, pharmacokinetics, biodistribution, tumor biopsies, and immune responses to huA33 were evaluated. RESULTS: There were 12 patients entered into the trial (6 males and 6 females; age range, 39-66 years). No dose-limitin..

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