eligibility_summary
Adults with HER2+ metastatic breast or gastric/GEJ/esophageal adenocarcinoma, consent, progression after HER2 therapy, tumor tissue for Phase II, recovered toxicities ≤G1 (exceptions), measurable disease (RECIST 1.1), ECOG 0–1. Exclude: recent other active cancers, significant CV disease (NYHA ≥III, recent MI/stroke/PE), ECG/QTcF>470, EF<50%, QT risk factors, pregnancy/nursing or within 7 months post HER2 therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06324357 (Beamion BCGC-1) tests: 1) Zongertinib (BI 1810631, Hernexeos) – an oral small-molecule HER2 tyrosine kinase inhibitor – alone or combined with: trastuzumab deruxtecan (T-DXd, anti-HER2 antibody–drug conjugate carrying a topoisomerase I inhibitor), trastuzumab emtansine (T-DM1, anti-HER2 ADC carrying the microtubule inhibitor DM1), trastuzumab (anti-HER2 monoclonal antibody), and capecitabine (oral 5-FU prodrug, antimetabolite). 2) Targets/pathways: HER2/ERBB2-overexpressing or amplified tumor cells in metastatic breast and gastroesophageal adenocarcinomas. Mechanistic actions include blockade of HER2 signaling (downstream PI3K/AKT/MAPK), immune-mediated ADCC (trastuzumab), DNA damage via topo I inhibition (T-DXd), microtubule disruption (T-DM1), and DNA/RNA synthesis inhibition (capecitabine).