dc.contributor
Institut Català de la Salut
dc.contributor
[Hurvitz S] Clinical Research Division, Fred Hutchinson Cancer Center, Division of Hematology/Oncology, Department of Medicine, The University of Washington, Seattle, WA, USA. [Simonelli M] Department of Medical Oncology and Hematology, IRCCS Humanitas Research Hospital, Milan, Italy. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy. [Yarza R] Drug Development and Phase 1 Unit, START CIOCC, Madrid, Spain. [Berz D] Department of Oncology, Valkyrie Clinical Trials, Inc, Los Angeles, CA, USA. [Kitano S] Department of Advanced Medical Development, Japanese Foundation for Cancer Research, Tokyo, Japan. [Del Conte G] Department of Oncology, IRCCS San Raffaele Scientific Institute Hospital, Milan, Italy. [Acosta Eyzaguirre D] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Hurvitz, Sara
dc.contributor.author
YARZA, RAMON
dc.contributor.author
Berz, David
dc.contributor.author
DEL CONTE, GIANLUCA
dc.contributor.author
Acosta Eyzaguirre, Daniel
dc.contributor.author
Simonelli, Matteo
dc.contributor.author
Kitano, Shigehisa
dc.date.accessioned
2026-03-09T08:15:08Z
dc.date.available
2026-03-09T08:15:08Z
dc.date.issued
2026-03-04T07:10:34Z
dc.date.issued
2026-03-04T07:10:34Z
dc.identifier
Hurvitz S, Simonelli M, Yarza R, Berz D, Kitano S, Del Conte G, et al. Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers. Futur Oncol. 2025;21(26):3385–93.
dc.identifier
http://hdl.handle.net/11351/14296
dc.identifier
10.1080/14796694.2025.2569553
dc.identifier
001597263000001
dc.identifier.uri
https://hdl.handle.net/11351/14296
dc.description.abstract
Zongertinib; Metastatic breast cancer; Esophageal adenocarcinoma
dc.description.abstract
Zongertinib; Cáncer de mama metastásico; Adenocarcinoma de esófago
dc.description.abstract
Zongertinib; Càncer de mama metastàtic; Adenocarcinoma d'esòfag
dc.description.abstract
Background
Overexpression and/or amplification of human epidermal growth factor receptor 2 (HER2) is a recognized oncogenic driver in metastatic breast cancer (mBC) and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinomas (mGEAC). Although HER2-directed monoclonal antibodies, antibody – drug conjugates (ADCs), and tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of HER2-positive tumors, additional combination regimens and/or novel agents are needed to expand sequential therapy options and improve patient outcomes – particularly following treatment with trastuzumab deruxtecan (T-DXd). Zongertinib is a novel, irreversible, HER2-selective TKI that spares EGFR.
Study design
Here, we detail the rationale and design of Beamion BCGC-1 (NCT06324357), an international Phase Ib/II open-label trial in which patients with previously treated HER2-positive mBC or mGEAC will receive zongertinib alone or in combination. Phase Ib (dose escalation) will determine the maximum tolerated dose of zongertinib plus trastuzumab emtansine (T-DM1), T-DXd, or trastuzumab ± capecitabine, in patients with HER2-positive mBC, and plus T-DXd in patients with HER2-positive mGEAC. Phase II (dose optimization) will assess two doses of zongertinib in combination regimens, or as monotherapy, in patients with mBC or mGEAC. The trial is actively recruiting in six countries globally.
Clinical trial registration
www.clinicaltrials.gov identifier is NCT06324357.
dc.description.abstract
This study was sponsored by Boehringer Ingelheim.
dc.format
application/pdf
dc.publisher
Taylor & Francis
dc.relation
Future Oncology;21(26)
dc.relation
https://doi.org/10.1080/14796694.2025.2569553
dc.rights
Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Proteïnes quinases - Inhibidors - Ús terapèutic
dc.subject
Mama - Càncer - Tractament
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Estómac - Càncer - Tractament
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Esòfag - Càncer - Tractament
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Medicaments - Relacions dosi-efecte
dc.subject
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors
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Other subheadings::Other subheadings::/therapeutic use
dc.subject
DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Stomach Neoplasms
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DISEASES::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Esophageal Neoplasms
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DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms
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Other subheadings::Other subheadings::Other subheadings::/drug therapy
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ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Toxicity Tests::Maximum Tolerated Dose
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COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas
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Otros calificadores::Otros calificadores::/uso terapéutico
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ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias gástricas
dc.subject
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias gastrointestinales::neoplasias del esófago
dc.subject
ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama
dc.subject
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::pruebas de toxicidad::dosis máxima tolerada
dc.title
Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
