eligibility_summary
Adults (≥18) with CLDN18.2-positive adenocarcinoma of stomach/GEJ/esophagus/pancreas, measurable disease (RECIST 1.1), ECOG 0–1, ≥12-week life expectancy, adequate organs, contraception, and ≥1 prior systemic therapy. Excludes unresolved ≥G2 toxicities, prior severe CRS/ICANS, HLH/MAS, recent autoimmune disease, recent CNS mets/pathology, active HIV/HBV/HCV/EBV or serious infections, cardiac issues, recent thromboembolism, chronic immunosuppression, or therapeutic anticoagulation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06005493 tests AZD5863, a T cell–engaging bispecific antibody (immunotherapy) given IV or SC in adults with advanced CLDN18.2-positive solid tumors (gastric, GEJ, pancreatic ductal, esophageal adenocarcinoma). Drug/intervention: AZD5863 binds Claudin 18.2 (on tumor cells) and CD3 (on T cells), redirecting and activating endogenous T cells to kill tumor cells. Mechanism of action: tumor antigen–dependent crosslinking of CD3 triggers TCR signaling, immune synapse formation, cytotoxic granule release, and tumor cell lysis, with associated cytokine production. Cells/pathways targeted: CLDN18.2-expressing epithelial tumor cells and CD3+ T lymphocytes, key pathways include CD3/TCR activation and downstream cytotoxic T-cell effector functions. Trial design: Phase I/II, open-label, dose escalation and expansion, monotherapy, first-in-human.