eligibility_summary
Adults ≥18 with confirmed locally advanced unresectable PDAC (Alliance criteria), ECOG 0-2, adequate organ function, ≥4 months NCCN chemo, FDG-PET performed and no metastases on recent CT/MRI, tumor <4 cm suitable for complete ablation, consent and contraception. Exclude: pregnancy/lactation, excipient allergy, fever, recent investigational drug, prior CD40 or pancreatic RT, severe autoimmune, metal in tumor/metallic cardiac device, uncontrolled arrhythmia, high-dose steroids, surgery contraindication, or metastasis.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06205849 (Phase 1, single-arm) tests intra-tumoral mitazalimab plus irreversible electroporation (IRE) in unresectable locally advanced pancreatic cancer. Interventions/mechanisms: 1) Mitazalimab—an agonistic anti-CD40 monoclonal antibody (immunotherapy) delivered intratumorally to activate CD40 signaling, boosting antigen presentation, dendritic cell activation, and T‑cell priming. 2) IRE (NanoKnife device)—non-thermal ablation that disrupts tumor cell membranes, causing cell death and releasing tumor antigens and inflammatory signals. Targets: CD40 pathway on antigen-presenting cells (dendritic cells, macrophages, B cells), enhancing cross-priming of cytotoxic T cells against tumor antigens, innate and adaptive immune activation within the ablated tumor microenvironment. Dose-escalation: 75→200 µg/kg (with possible de-escalation). Purpose: enhance IRE-induced immunity and reduce recurrence.