eligibility_summary
Eligibility: HER2+ breast adenocarcinoma, ≥2 prior anti-HER2 lines including trastuzumab deruxtecan (≥1 metastatic), measurable disease (RECIST 1.1), ECOG 0–1, life expectancy >12 weeks, biopsy required or archival tissue. Exclude: severe allergy to BDC-1001/pertuzumab, TLR7/8 agonist/ISACs within 12 months, significant cardiac disease, active HIV/HBV/HCV, CNS mets unless asymptomatic, stable, steroid-free ≥28 days.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 randomized, open-label trial in HER2+ metastatic breast cancer post-trastuzumab deruxtecan tested: 1) BDC-1001 (single agent) and 2) BDC-1001 + pertuzumab. BDC-1001 is an immune-stimulating antibody conjugate (ISAC): a trastuzumab-biosimilar monoclonal antibody linked via a non-cleavable, cell-impermeable linker to a TLR7/8 agonist. Mechanism: binds HER2 on tumor cells to localize TLR7/8 activation, triggering innate (via myeloid/APC TLR7/8) and subsequent adaptive anti-tumor immunity. Pertuzumab is an anti-HER2 monoclonal antibody that prevents HER2 heterodimerization (with HER1/EGFR, HER3, HER4), blocking ligand-activated downstream signaling. Targets/pathways: HER2 on tumor cells, TLR7/8 innate immune pathway in antigen-presenting cells, HER family receptor dimerization/signaling. Status: terminated (sponsor decision).