A Phase I dose-escalation study of sibrotuzumab in patients with advanced or metastatic fibroblast activation protein-positive cancer.
Andrew M Scott, Greg Wiseman, Sydney Welt, Alex Adjei, Fook-Thean Lee, Wendie Hopkins, Chaitan R Divgi, Lorelei H Hanson, Paul Mitchell, Denise N Gansen, Steven M Larson, James N Ingle, Eric W Hoffman, Paul Tanswell, Gerd Ritter, Leonard S Cohen, Peter Bette, Lisa Arvay, Andree Amelsberg, Dan Vlock Show all
Clinical Cancer Research | Published : 2003
PURPOSE: The purpose of this research was to determine the safety, immunogenicity, pharmacokinetics, biodistribution, and tumor uptake of repeat infusions of a complementarity-determining region grafted humanized antibody (sibrotuzumab) directed against human fibroblast activation protein (FAP). EXPERIMENTAL DESIGN: A Phase I open-label dose escalation study was conducted in patients with cancers epidemiologically known to be FAP positive. Patients were entered into one of four dosage tiers of 5, 10, 25, or 50 mg/m(2) sibrotuzumab, administered weekly for 12 weeks, with trace labeling with 8-10 mCi of (131)I in weeks 1, 5, and 9. RESULTS: A total of 26 patients were entered into the trial (1..View full abstract