eligibility_summary
Incl: adults ≥18 with recurrent/metastatic ESCC, RECIST‑measurable, ECOG 0–1, life ≥3 mo, adequate organs/LVEF ≥50%, tumor tissue, prior AEs ≤G1, negative pregnancy test/contraception. Excl: recent therapy (≤4 w/5 t½, RT/TCM ≤2 w), eligible for radical local Rx, prior topo‑I ADCs, major cardiac/QT/cerebrovascular disease, ILD/severe lung disease or active CNS mets, recent serious infection, significant GI disease, allergy, prior SCT, HIV/active HBV/HCV or recent trials/live vaccines.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06304974 (Phase 3) in recurrent/metastatic esophageal squamous cell carcinoma after failure of PD‑1/PD‑L1 + platinum therapy. Interventions and mechanisms: • BL‑B01D1 (iza‑bren, izalontamab brengitecan, BMS‑986507): an antibody‑drug conjugate (ADC) targeting TROP2. Humanized IgG1 mAb delivers a camptothecin/topoisomerase‑I inhibitor payload (“‑gitecan”) via a cleavable linker. Binds TROP2 on tumor cells, internalizes, releases payload to inhibit Topo‑I, causing DNA damage/apoptosis, potential Fc‑mediated ADCC/CDC and bystander effect. • Control (physician’s choice chemo): irinotecan (small‑molecule Topo‑I inhibitor prodrug to SN‑38), paclitaxel or docetaxel (taxane small‑molecule microtubule stabilizers). Cells/pathways targeted: • TROP2‑expressing esophageal squamous carcinoma cells. • DNA replication/repair via Topo‑I (BL‑B01D1, irinotecan). • Mitotic spindle/microtubule dynamics (paclitaxel, docetaxel).