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LBA4001 : 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.

Researchers

Presenter

  • Salah-Eddin Al-Batran

Principal Investigators

  • Zanete Zvirbule

  • Georgiy Manikhas

  • Florian Lordick

  • Andriy Rusyn

  • Yuriy Vynnyk

  • Ihor Vynnychenko

  • Natalia Fadeeva

  • Marina Nechaeva

  • Assen Dudov

  • Evgeny Gotovkin

  • Alexander Pecheniy

  • Igor Bazin

  • Igor Bondarenko

  • Bohuslav Melichar

  • Christian Mueller

  • Christoph Huber

  • Oezlem Tureci

  • Ugur Sahin

Medical Centers

  • Institute of Clinical Cancer Research, Nordwest Hospital, Frankfurt Am Main, Germany

  • Department of Medical Oncology, West German Cancer Center, University Duisburg-Essen, and German Cancer Consortium (DKTK), Partner site University Hospital Essen, Essen, Germany

  • Riga East University Hospital, LLC, Riga, Latvia

  • City Clinical Oncology Dispensary, St. Petersburg, Russia

  • University Cancer Center Leizpig, University Medicine Leipzig, Leipzig, Germany

  • Zakarpattya Regional Clinical Oncological Center, Department of Chemotherapy, Uzhgorod, Ukraine

  • Kharkiv Regional Clinical Oncology Center, Abdominal Department, Kharkiv, Ukraine

  • Sumy Regional Clinical Oncology Center, Oncothoracic Department, Sumy State University, Sumy, Ukraine

  • Arkhangelsk Regional Clinical Oncologic Dispensary, Arkhangelsk, Russia

  • Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia, University Hospital City Clinic Oncology Center, Sofia, Bulgaria

  • Ivanovo Regional Oncology Dispensary, Ivanovo, Russia

  • Dnipropetrovsk Medical Academy, City Multispecialty Clinical Hospital #4, Department of Chemotherapy, Dnipropetrovsk, Ukraine

  • Palacky University Medical School & Teaching Hospital, Olomouc, Czech Republic

  • Ganymed Pharmaceuticals AG, Mainz, Germany

  • TRON Translational Oncology at the University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany

Locations

  • Czech Republic

  • Latvia

  • Germany

  • Bulgaria

  • Ukraine

  • Russia

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Solid malignancies

Biomarkers

  • N/A

Drug/Treatment

  • Capecitabine

  • Trastuzumab

  • Oxaliplatin

  • Epirubicin

  • imAb362

Outcome

  • N/A

Study Design

  • Randomized

  • Multinational

  • Multicenteric

Phase

  • II

Study Id's

  • NCT01630083

Sponsors

  • N/A

Result

  • Final

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