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dc.contributor.authorScott, Andrew Men
dc.contributor.authorTebbutt, Niall Cen
dc.contributor.authorLee, Fook-Theanen
dc.contributor.authorCavicchiolo, Tinaen
dc.contributor.authorLiu, Zhanqien
dc.contributor.authorGill, Sanjeeven
dc.contributor.authorPoon, Aurora M Ten
dc.contributor.authorHopkins, Wendieen
dc.contributor.authorSmyth, Fiona Een
dc.contributor.authorMurone, Carmelen
dc.contributor.authorMacGregor, Duncanen
dc.contributor.authorPapenfuss, Anthony Ten
dc.contributor.authorChappell, Bridgeten
dc.contributor.authorSaunder, Timothy Hen
dc.contributor.authorBrechbiel, Martin Wen
dc.contributor.authorDavis, Ian Den
dc.contributor.authorMurphy, Rogeren
dc.contributor.authorChong, Geoffreyen
dc.contributor.authorHoffman, Eric Wen
dc.contributor.authorOld, Lloyd Jen
dc.identifier.citationClinical Cancer Research; 13(11): 3286-92en
dc.description.abstractWe report a first-in-man trial of a humanized antibody (hu3S193) against the Le(y) antigen.Patients with advanced Le(y)-positive cancers received four infusions of hu3S193 at weekly intervals, with four dose levels (5, 10, 20, and 40 mg/m(2)). The first infusion of hu3S193 was trace labeled with Indium-111, and biodistribution, pharmacokinetics, tumor uptake, and immune response were evaluated in all patients.A total of 15 patients (7 male/8 female; age range, 42-76 years; 6 breast, 8 colorectal cancer, and 1 non-small-cell lung cancer) were entered into the study. Transient grade 1 to 2 nausea and vomiting was observed following infusion of hu3S193 at the 40 mg/m(2) dose level only. There was one episode of dose-limiting toxicity with self-limiting Common Toxicity Criteria grade 3 elevated alkaline phosphatase observed in one patient with extensive liver metastases. The biodistribution of (111)In-hu3S193 showed no evidence of any consistent normal tissue uptake, and (111)In-hu3S193 uptake was observed in cutaneous, lymph node, and hepatic metastases. Hu3S193 displayed a long serum half-life (T(1/2)beta = 189.63 +/- 62.17 h). Clinical responses consisted of 4 patients with stable disease and 11 patients with progressive disease, although one patient experienced a 89% decrease in a lymph node mass, and one patient experienced inflammatory symptoms in cutaneous metastases, suggestive of a biological effect of hu3S193. No immune responses (human anti-human antibody) to hu3S193 were observed.Hu3S193 is well tolerated and selectively targets tumors, and the long half-life and biological function in vivo of this antibody makes it an attractive potential therapy for patients with Le(y)-expressing cancers.en
dc.subject.otherAntibodies, Monoclonal.adverse effects.pharmacokinetics.therapeutic useen
dc.subject.otherAntibodies, Monoclonal, Humanizeden
dc.subject.otherIndium Radioisotopes.pharmacokineticsen
dc.subject.otherLewis Blood-Group System.biosynthesisen
dc.subject.otherMiddle Ageden
dc.subject.otherSkin Neoplasms.therapyen
dc.subject.otherTime Factorsen
dc.subject.otherTissue Distributionen
dc.subject.otherTreatment Outcomeen
dc.titleA phase I biodistribution and pharmacokinetic trial of humanized monoclonal antibody Hu3s193 in patients with advanced epithelial cancers that express the Lewis-Y antigen.en
dc.typeJournal Articleen
dc.identifier.journaltitleClinical Cancer Researchen
dc.identifier.affiliationLudwig Institute for Cancer Research, Melbourne Tumour Biology Branch, Austin Hospital, Australiaen
dc.type.austinJournal Articleen, Geoffrey
item.openairetypeJournal Article-
item.fulltextNo Fulltext-
item.grantfulltextnone- Imaging and Therapy- Newton-John Cancer Research Institute- Oncology- Newton-John Cancer Wellness and Research Centre- Imaging and Therapy- Newton-John Cancer Research Institute- Newton-John Cancer Wellness and Research Centre-
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