eligibility_summary
Adults 18–75, consented, ECOG 0–1, life ≥12 wks, adequate marrow/organ function. Escalation: advanced solid tumors after standard-therapy failure/intolerance, Expansion: metastatic urothelial or other advanced tumors, RECIST measurable/evaluable. Contraception. Exclude: recent trial/anti-tumor therapy, prior Nectin-4, unresolved >G1 AEs, recent major surgery, transplant, uncontrolled CNS mets, other active malignancy, major CV/QTc disease, ILD/pneumonitis, active infections incl. TB/HIV/HBV/HCV/syphilis, severe allergy, uncontrolled effusions, high bleed/thrombosis risk, serious comorbidity or psychiatric/substance issues, pregnancy/lactation, recent live vaccine, prior ≥G3 topo-I toxicity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: BAT8007 for injection—an antibody-drug conjugate (ADC) consisting of a fully human anti–Nectin‑4 monoclonal antibody linked to exatecan. Mechanism of action: The antibody binds Nectin‑4 on tumor cells, is internalized, and releases exatecan, a topoisomerase I inhibitor that traps Topo I–DNA complexes, causing replication-associated DNA damage and tumor cell death. Cells/pathways targeted: Nectin‑4 (PVRL4), a cell-adhesion molecule overexpressed on many epithelial solid tumors, notably urothelial carcinoma, intracellular target is the nuclear topoisomerase I/DNA replication machinery, with greatest impact on proliferating tumor cells. Context: Phase I, IV Q3W dose-escalation/expansion in advanced solid tumors to assess safety, tolerance, and pharmacokinetics.