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First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors
DC Field | Value | Language |
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dc.contributor.author | Bang, Y. J. | - |
dc.contributor.author | Giaccone, G. | - |
dc.contributor.author | Im, S. A. | - |
dc.contributor.author | Oh, D. Y. | - |
dc.contributor.author | Bauer, T. M. | - |
dc.contributor.author | Nordstrom, J. L. | - |
dc.contributor.author | Li, H. | - |
dc.contributor.author | Chichili, G. R. | - |
dc.contributor.author | Moore, P. A. | - |
dc.contributor.author | Hong, S. | - |
dc.contributor.author | Stewart, S. J. | - |
dc.contributor.author | Baughman, J. E. | - |
dc.contributor.author | Lechleider, R. J. | - |
dc.contributor.author | Burris, H. A. | - |
dc.date.accessioned | 2021-01-31T11:57:40Z | - |
dc.date.available | 2021-01-31T11:57:40Z | - |
dc.date.created | 2018-08-20 | - |
dc.date.created | 2018-08-20 | - |
dc.date.created | 2018-08-20 | - |
dc.date.created | 2018-08-20 | - |
dc.date.issued | 2017-04 | - |
dc.identifier.citation | Annals of Oncology, Vol.28 No.4, pp.855-861 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.other | 44815 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173163 | - |
dc.description.abstract | Background: Margetuximab is an anti-HER2 antibody that binds with elevated affinity to both the lower and higher affinity forms of CD16A, an Fc-receptor important for antibody dependent cell-mediated cytotoxicity (ADCC) against tumor cells. A Phase 1 study was initiated to evaluate the toxicity profile, maximum tolerated dose (MTD), pharmacokinetics, and antitumor activity of margetuximab in patients with HER2-overexpressing carcinomas. Patients and methods: Patients with HER2-positive breast or gastric cancer, or other carcinomas that overexpress HER2, for whom no standard therapy was available, were treated with margetuximab by intravenous infusion at doses of 0.1-6.0 mg/kg for 3 of every 4 weeks (Regimen A) or once every 3 weeks (10-18 mg/kg) (Regimen B). Results: Sixty-six patients received margetuximab (34 patients for Regimen A and 32 patients for Regimen B). The MTD was not reached for either regimen. Treatment was well-tolerated, with mostly Grade 1 and 2 toxicities consisting of constitutional symptoms such as pyrexia, nausea, anemia, diarrhea, and fatigue. Among 60 response-evaluable patients, confirmed partial responses and stable disease were observed in 7 (12%) and 30 (50%) patients, respectively; 26 (70%) of these patients had received prior HER2-targeted therapy. Tumor reductions were observed in over half (18/23, 78%) of response-evaluable patients with breast cancer including durable (>30 weeks) responders. Ex vivo analyses of patient peripheral blood mononuclear cell samples confirmed the ability of margetuximab to support enhanced ADCC compared with trastuzumab. Conclusions: Margetuximab was well-tolerated and has promising single-agent activity. Further development efforts of margetuximab as single agent and in combination with other therapeutic agents are ongoing. | - |
dc.language | 영어 | - |
dc.publisher | Oxford University Press | - |
dc.title | First-in-human phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 임석아 | - |
dc.identifier.doi | 10.1093/annonc/mdx002 | - |
dc.citation.journaltitle | Annals of Oncology | - |
dc.identifier.wosid | 000397622100031 | - |
dc.identifier.scopusid | 2-s2.0-85015678089 | - |
dc.citation.endpage | 861 | - |
dc.citation.number | 4 | - |
dc.citation.startpage | 855 | - |
dc.citation.volume | 28 | - |
dc.identifier.sci | 000397622100031 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Y. J. | - |
dc.contributor.affiliatedAuthor | Im, S. A. | - |
dc.contributor.affiliatedAuthor | Oh, D. Y. | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | METASTATIC BREAST-CANCER | - |
dc.subject.keywordPlus | RECEPTOR POLYMORPHISMS | - |
dc.subject.keywordPlus | ADJUVANT CHEMOTHERAPY | - |
dc.subject.keywordPlus | TRASTUZUMAB | - |
dc.subject.keywordPlus | PHARMACOKINETICS | - |
dc.subject.keywordPlus | PLUS | - |
dc.subject.keywordPlus | EFFICACY | - |
dc.subject.keywordAuthor | margetuximab | - |
dc.subject.keywordAuthor | HER2 | - |
dc.subject.keywordAuthor | solid tumor | - |
dc.subject.keywordAuthor | breast cancer | - |
dc.subject.keywordAuthor | gastric cancer | - |
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