eligibility_summary
Adults 18–75 with unresectable locally advanced, recurrent, or metastatic HER2‑positive (IHC3+ or FISH+) breast cancer, previously treated with T‑DXd, with adequate marrow, liver, renal, and coagulation function, and able to consent/comply. Excludes active/leptomeningeal/disseminated brain mets, ILD or pneumonitis history/active ILD, eye disease needing treatment, cardiac insufficiency, recent systemic therapy (≤28 days/≤5 half‑lives, endocrine ≥7 days).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06578286 is a single-arm, phase 2 trial in HER2-positive metastatic breast cancer after progression on T-DXd. Intervention: ARX788, a HER2-directed antibody-drug conjugate (biologic). Mechanism: a humanized anti-HER2 monoclonal antibody binds HER2 on tumor cells, is internalized, and releases a potent microtubule-inhibiting cytotoxic payload (auristatin/Amberstatin analog) via lysosomal processing, disrupting tubulin, causing mitotic arrest and apoptosis. Target cells/pathways: HER2-overexpressing breast cancer cells, HER2 receptor-mediated endocytosis, microtubule/tubulin cytoskeleton. Dosing: 1.5 mg/kg IV every 3 weeks.