A Phase I Dose-Escalation Study of Sibrotuzumab in Patients with Advanced Or Metastatic Fibroblast Activation Protein-Positive Cancer1
Vol. 9, 1639–1647, May 2003 Clinical Cancer Research 1639 A Phase I Dose-Escalation Study of Sibrotuzumab in Patients with Advanced or Metastatic Fibroblast Activation Protein-positive Cancer1 Andrew M. Scott,2 Greg Wiseman, Sydney Welt, first 12 weeks of the study, with 24 patients being evaluable. Alex Adjei, Fook-Thean Lee, Wendie Hopkins, One patient received an additional 96 infusions on contin- Chaitan R. Divgi, Lorelei H. Hanson, ued-use phase for a total of 108 infusions over a 2-year period, and 1 patient received an additional 6 infusions on Paul Mitchell, Denise N. Gansen, continued use. There were no objective tumor responses. Steven M. Larson, James N. Ingle, Only one episode of dose-limiting toxicity was observed. Eric W. Hoffman, Paul Tanswell, Gerd Ritter, Therefore, a maximum tolerated dose was not reached. Leonard S. Cohen, Peter Bette, Lisa Arvay, Treatment-related adverse events were observed in 6 pa- Andree Amelsberg, Dan Vlock, tients during the infusional monitoring period. Four of the 6 Wolfgang J. Rettig, and Lloyd J. Old patients, 3 of whom had associated positive serum human antihuman antibody, were removed from the study because Ludwig Institute for Cancer Research, Melbourne Tumour Biology Austin, and Repatriation Medical Centre, Melbourne, 3084 Australia of clinical immune responses. Gamma camera images of [A. M. S., F-T. L., W. H., P. M.]; Mayo Clinic, Rochester, Minnesota [131I]sibrotuzumab demonstrated no normal organ uptake 55905 [G. W., A. Ad., L., H. H., D. N. G., J. N. I.]; Memorial Sloan of sibrotuzumab, with tumor uptake evident within 24–48 h Kettering Cancer Center, New York, New York 10021 [S.
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