eligibility_summary
Inclusion: Adults 18–75 with unresectable/metastatic HER2+ breast cancer, measurable disease (RECIST 1.1), ECOG 0–1, ≥3‑mo survival, adequate cardiac (LVEF ≥50%) and organ function, tumor tissue available, effective contraception/negative pregnancy. Exclusion: Prior systemic therapy for advanced disease, recent chemo/surgery/endocrine or camptothecin‑ADC, major cardiac/respiratory (incl ILD/QT) disease, active CNS mets, autoimmune or active infections (HBV/HCV/HIV), transplant, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions and mechanisms: • BL-M07D1: HER2-directed antibody–drug conjugate (ADC). Binds HER2 on tumor cells, is internalized, and releases a camptothecin-derived topoisomerase I inhibitor payload to induce DNA damage, Fc may trigger ADCC. • Pertuzumab: Humanized anti-HER2 monoclonal antibody that binds HER2 domain II to block ligand-dependent dimerization (HER2/HER3, HER2/EGFR), suppressing downstream PI3K/AKT and MAPK signaling, can mediate ADCC. • Docetaxel: Taxane chemotherapeutic that stabilizes microtubules, causing mitotic arrest and apoptosis. Cells/pathways targeted: HER2-overexpressing breast cancer cells, HER2 receptor dimerization/signaling (PI3K/AKT, MAPK), DNA replication via topo I inhibition, mitotic spindle/microtubules, immune-mediated cytotoxicity against HER2+ cells.