A phase I multiple dose, dose escalation study of cG250 monoclonal antibody in patients with advanced renal cell carcinoma.
Ian D Davis, Gregory A Wiseman, Fook-Thean Lee, Denise N Gansen, Wendie Hopkins, Anthony T Papenfuss, Zhanqi Liu, Timothy J Moynihan, Gary A Croghan, Alex A Adjei, Eric W Hoffman, James N Ingle, Lloyd J Old, Andrew M Scott
Cancer Immun | Published : 2007
The chimeric monoclonal antibody cG250 recognises the G250/CAIX/MN antigen found on 95% of clear cell renal cell carcinomas (RCCs). We performed a phase I clinical trial to evaluate the safety, blood pharmacokinetics (PK), and biodistribution of repeated doses of cG250. The primary endpoint was toxicity. Secondary endpoints were cG250 biodistribution and PK; measurement of human anti-chimeric-antibodies (HACA); and tumour response rates. Eligible patients had unresectable or metastatic clear cell RCC. Doses of 5, 10, 25, or 50 mg/m(2) were given weekly by intravenous infusion for six weeks. Three patients were treated at each dose level. Trace (131)I-labelled cG250 was administered on weeks ..View full abstract