eligibility_summary
Adults ≥18 with ECOG 0–1, confirmed PDAC after R0/R1 resection 21–84 days prior, no metastases, recovered from surgery, acceptable labs, FFPE tissue available, agree to PK/contraception. Exclude: pregnant/breastfeeding, recent major surgery, cardiac/QT risk, prior PDAC therapy, active infections (HIV low CD4, HBV, HCV, TB), CA19-9>180, R2, neuropathy, GI disease, UGT1A128 homozygous, DPD deficiency, recent live vaccine, hypersensitivity, mFOLFIRINOX contraindication, other trials/vulnerable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Adjuvant mFOLFIRINOX ± BNT321 after curative resection for PDAC (terminated by sponsor, not for safety). Interventions/mechanisms: • BNT321: fully human IgG1 monoclonal antibody targeting CA19-9 (sialyl-Lewis A) on tumor cells, type: antibody immunotherapy. Mechanisms: direct binding to CA19-9+ cells, Fc-mediated antibody-dependent cell-mediated cytotoxicity (ADCC) via NK/macrophages (FcγR), and complement-dependent cytotoxicity (CDC). • mFOLFIRINOX: cytotoxic chemotherapy (5-fluorouracil + leucovorin, irinotecan, oxaliplatin). Mechanisms: 5-FU inhibits thymidylate synthase (DNA synthesis), leucovorin enhances 5-FU, irinotecan (SN-38) inhibits topoisomerase I, oxaliplatin forms DNA crosslinks. Targets/cellular pathways: • CA19-9/sLea-expressing pancreatic cancer cells. • Immune effector pathways: NK cell–mediated ADCC, complement cascade (CDC). • Tumor DNA replication/repair pathways and cell cycle in rapidly dividing cells.