eligibility_summary
Adults 18–75 with unresectable/metastatic TNBC, ECOG 0–1, ≥3‑mo survival, measurable disease, prior 1–2 lines incl taxane, tumor tissue available, eligible for eribulin/capecitabine/gemcitabine/vinorelbine, treated, stable brain mets allowed, adequate organs, LVEF ≥50%, negative pregnancy test/contraception. Exclude prior TOP1‑ or EGFR/HER3‑ADCs, recent therapy, high anthracycline, major CV/thrombotic/QT/ILD/pulmonary/CNS/GI disease, active infection/HBV/HCV/HIV, immunosuppression, live vaccines.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase III in unresectable/metastatic triple‑negative breast cancer after taxane failure. Interventions and mechanisms: • BL‑B01D1 (izalontamab brengitecan, BMS‑986507): bispecific antibody–drug conjugate (ADC) targeting EGFR and HER3. Upon binding and internalization, a cleavable linker releases a topoisomerase I–inhibitor payload, causing DNA single‑strand breaks and apoptosis, potential bystander killing. • Physician’s choice chemotherapy: – Eribulin: microtubule dynamics inhibitor (halichondrin analog). – Vinorelbine: vinca alkaloid, inhibits microtubule polymerization. – Gemcitabine: antimetabolite nucleoside analog, inhibits ribonucleotide reductase and DNA synthesis. – Capecitabine: oral 5‑FU prodrug, inhibits thymidylate synthase. Targets/pathways: EGFR (ERBB1) and HER3 (ERBB3) on tumor cells, DNA topoisomerase I, microtubules, DNA synthesis/TS, downstream ErbB signaling (PI3K/AKT/MAPK).