Phase 1 ELI-002 7P KRAS-targeted amphiphile peptide vaccine with mFOLFIRINOX ± PD-1 blockade

This Memorial Sloan Kettering Cancer Center–led, open-label, multi-institution pilot study tests neoadjuvant mFOLFIRINOX (5-FU/leucovorin + irinotecan + oxaliplatin cytotoxic chemotherapy) combined with ELI-002 7P, Elicio Therapeutics’ lymph-node–targeted “Amph” (lipid-conjugated) multi-peptide therapeutic cancer vaccine designed to generate T-cell immunity against the 7 most prevalent mutant KRAS variants. A second cohort adds tislelizumab, BeiGene’s PD-1 (CD279)–blocking monoclonal antibody, to assess whether checkpoint inhibition can amplify vaccine-primed anti-tumor T-cell activity in typically immune-resistant PDAC. Eligible patients have resectable or borderline resectable pancreatic ductal adenocarcinoma with a KRAS mutation (KRAS alterations are highly prevalent in PDAC, ~90%+). The key angle is bringing a KRAS-directed, off-the-shelf immunotherapy into the curative-intent window rather than only after relapse. Today’s care for resectable/borderline-resectable PDAC is neoadjuvant multi-agent chemo (commonly mFOLFIRINOX) followed by surgery when feasible, then additional systemic therapy, with recurrence risk remaining high—this trial probes whether adding KRAS-specific immunization ± PD-1 blockade can deepen pathologic response and reduce early relapse.