eligibility_summary
Include: Adults 18–75, ECOG 0–1, ≥3‑mo survival, confirmed unresectable/locally advanced/recurrent/metastatic TNBC, no prior systemic therapy for advanced disease, measurable lesion, tumor tissue available, adequate organs, prior AEs ≤G1, negative pregnancy/contraception. Exclude: prior topo‑I ADCs or checkpoint inhibitors, recent RT/immunomodulators/steroids, major cardiac/QT issues, uncontrolled DM/HTN, serious lung disease or CNS mets, unstable thrombosis, active infection or recent other cancer, recent trial/live vaccine, allergy, psych illness/substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06471205 (phase II, single-arm) in unresectable/metastatic triple‑negative breast cancer. Interventions/mechanisms: 1) BL‑B01D1 (iza‑bren, izalontamab brengitecan, BMS‑986507) – an antibody‑drug conjugate (ADC). The monoclonal antibody binds a tumor‑associated surface antigen on TNBC cells and is internalized, releasing a camptothecin‑class topoisomerase I inhibitor (“brengitecan”) to induce DNA damage and apoptosis, with potential bystander effect. 2) PD‑1 monoclonal antibody (per MeSH: spartalizumab) – an immune checkpoint inhibitor (IgG4) that blocks PD‑1 on T cells, reversing PD‑1/PD‑L1–mediated suppression to restore antitumor cytotoxicity. Targets/pathways: tumor cells expressing the ADC’s antigen, DNA replication/repair via topoisomerase I inhibition, PD‑1 checkpoint on CD8+ T cells within the tumor microenvironment.