eligibility_summary
Adults 18–75 with recurrent/metastatic NPC post PD‑1/PD‑L1 and ≥2 chemo (incl platinum), control chemo–eligible, measurable disease, ECOG 0–1, expected survival ≥3 mo, adequate organ/cardiac function, contraception. Exclude recent therapy, curative local therapy candidates, prior topo‑I or EGFR/HER3 ADCs, major cardiac/vascular disease, other active cancer, uncontrolled HTN/DM, ILD/lung disease, CNS mets, infections/effusions, HIV/HBV/HCV, transplant, severe GI disease/bleeding, live vaccines.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III R/M nasopharyngeal carcinoma trial comparing: 1) BL-B01D1 (izalontamab brengitecan, BMS-986507), a bispecific antibody-drug conjugate (ADC) targeting EGFR and HER3. Mechanism: binds EGFR/HER3 on tumor cells, is internalized, and releases a topoisomerase I inhibitor payload (brengitecan) causing DNA damage and cell death, targets the ERBB pathway (EGFR/HER3→PI3K/AKT/MAPK). 2) Physician’s-choice chemotherapy: capecitabine (oral 5-FU prodrug, antimetabolite inhibiting thymidylate synthase), gemcitabine (nucleoside analog, ribonucleotide reductase inhibition and DNA incorporation/chain termination), and docetaxel (taxane, microtubule stabilizer blocking mitosis). Targets: EGFR/HER3-positive NPC cells, DNA synthesis/repair and mitotic pathways in rapidly dividing cells.