eligibility_summary
Inclusion: adults 18–75 with unresectable/metastatic solid tumors, measurable disease, ECOG 0–1, life ≥3 months, adequate organs, ≥3-week washout, tumor tissue in expansion, contraception. Exclusion: active/untreated CNS mets, significant effusions, recent GI perforation/fistula/bleeding or major surgery, serious CV/neuro/psych disease or ≥Grade 2 neuropathy, pregnancy, severe prior IO AEs, steroids/immunosuppression, unresolved AEs, mAb/AK132 allergy, prior CD47–SIRPα/CLDN18.2, active autoimmune disease, active infection (TB/HBV/HCV/HIV) or ILD/pneumonitis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06166472 (Phase 1, single-arm) testing AK132 in advanced solid tumors. Intervention: AK132, an IV, Q2W bispecific monoclonal antibody (immunotherapy) targeting CLDN18.2 and CD47. Mechanism: • CLDN18.2 arm binds a tumor-associated tight junction protein on malignant epithelial cells (e.g., gastric/GEJ, pancreatic), concentrating the drug in tumors. • CD47 arm blocks the CD47–SIRPα “don’t eat me” checkpoint, releasing macrophage phagocytosis (ADCP) and enhancing antigen presentation, Fc effector may recruit ADCC/CDC. • Bispecific design aims to focus CD47 blockade on CLDN18.2+ tumors to reduce off‑tumor hematologic toxicity. Targeted cells/pathways: CLDN18.2+ tumor cells, innate immune cells (macrophages via SIRPα), dendritic cells, potential NK involvement via Fc. Endpoints: safety, tolerability, PK, preliminary antitumor activity.