eligibility_summary
Eligible: 18–75, ECOG 0–1, ≥3‑mo survival, advanced/metastatic HER2‑negative breast cancer post standard tx, measurable disease, tissue available, adequate organ function. Exclude: prior topo‑I ADCs, recent anticancer therapy, immunomodulators or systemic steroids, severe irAEs, serious CV/CNS disease, ILD or active autoimmune, uncontrolled comorbidities or recent thrombosis, active/unstable CNS mets, allergy, prior transplant, active HIV/TB/HBV/HCV or serious infection, recent trials or substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: 1) BL-B01D1 (iza-bren, izalontamab brengitecan, BMS-986507) – an antibody-drug conjugate (ADC) directed at TROP2 on tumor cells. It delivers a camptothecin-derived topoisomerase I inhibitor (brengitecan) to cause DNA damage and apoptosis. 2) SI-B003 – an immune checkpoint monoclonal antibody that blocks the PD-1/PD-L1 axis (type: mAb), aiming to restore antitumor T-cell activity. Target cells/pathways: • TROP2-expressing breast cancer cells, intracellular topoisomerase I/DNA replication machinery (via ADC payload). • PD-1/PD-L1 immune checkpoint on T cells and tumor/immune cells, enhancing T-cell activation within the tumor microenvironment. Population: unresectable/metastatic HER2-negative breast cancer.