eligibility_summary
Eligible patients must consent, be from a DS or DS/AZ parent study at end-of-study, and have no disease progression with investigator-assessed clinical benefit. Exclude those with unresolved adverse events requiring discontinuation, or a gap >18 weeks (126 days) off T-DXd between the parent study and this study.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: T-DXd (trastuzumab deruxtecan, DS-8201a), an antibody–drug conjugate given IV every 3 weeks in a rollover, single-arm study. Mechanism of action: the trastuzumab antibody targets HER2 on tumor cells, is internalized, and releases the deruxtecan payload, a potent topoisomerase I inhibitor, causing DNA damage and apoptosis, the membrane-permeable payload enables a bystander effect, the Fc region may also mediate ADCC. Cells/pathways targeted: HER2-expressing (including HER2-low) tumor cells, HER2 receptor pathway, DNA replication/repair through topoisomerase I inhibition. Purpose: continued access and long-term safety in advanced/metastatic cancers benefiting from prior T-DXd.