FAST: An international, multicenter, randomized, phase II trial of epirubicin, oxaliplatin, and capecitabine (EOX) with or without IMAB362, a first-in-class anti-CLDN18.2 antibody, as first-line therapy in patients with advanced CLDN18.2+ gastric and gastroesophageal junction (GEJ) adenocarcinoma

Al-Batran, Salah-Eddin and Schuler, Martin H. and Zvirbule, Zanete and Manikhas, Georgiy and Lordick, Florian and Rusyn, Andriy and Vynnyk, Yuriy and Vynnychenko, Ihor and Fadeeva, Natalia and Nechaeva, Marina and Dudov, Assen and Gotovkin, Evgeny and Pecheniy, Alexander and Bazin, Igor and Bondarenko, Igor and Melichar, Bohuslav and Mueller, Christian and Huber, Christoph and Tureci, Oezlem and Sahin, Ugur (2016) FAST: An international, multicenter, randomized, phase II trial of epirubicin, oxaliplatin, and capecitabine (EOX) with or without IMAB362, a first-in-class anti-CLDN18.2 antibody, as first-line therapy in patients with advanced CLDN18.2+ gastric and gastroesophageal junction (GEJ) adenocarcinoma. Journal of Clinical Oncology, Vol 34 (No18_s). P.-LBA4001. ISSN 0732-183X (Print) ; 1527-7755 (Electronic) ; 0732-183X (Linking)

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Official URL: http://ascopubs.org/doi/abs/10.1200/JCO.2016.34.18...

Abstract

Background: Claudin18.2 (CLDN18.2) is a tight junction protein expressed by several cancers including gastric and GEJ adenocarcinoma. IMAB362 is a chimeric monoclonal antibody that mediates specific killing of CLDN18.2-positive cancer cells by activation of immune effector mechanisms. IMAB362 has demonstrated single-agent activity and was safe and tolerable in patients (pts) with pretreated gastric cancer. Methods: Pts with advanced/recurrent gastric and GEJ cancer were centrally evaluated for CLDN18.2 expression by IHC (validated CLAUDETECT18.2 Kit). Eligible pts had a CLDN18.2 expression of ≥ 2+ in ≥ 40% tumor cells, an ECOG PS of 0–1 and were not eligible for trastuzumab. Pts were randomized 1:1 to first-line EOX...

Item Type: Article
Subjects: Oncology
Gastroenterology
Neoplasms
Divisions: Departments > Department of Oncology and Medical Radiology
Depositing User: Елена Шрамко
Date Deposited: 11 Oct 2016 07:11
Last Modified: 12 Sep 2017 13:16
URI: http://repo.dma.dp.ua/id/eprint/1042

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