ELI-002 7P + mFOLFIRINOX ± Tislelizumab

a subcutaneous (SC) injection under the skin

neoadjuvant mFOLFIRINOX (5-Fluorouracil,oxaliplatin, leucovorin, irinotecan)

This is an open-label, multi-institution pilot study of neoadjuvant mFOLFIRINOX (5-Fluorouracil, oxaliplatin, leucovorin, irinotecan) and a lipid-conjugated Kristin-Ras (KRAS) therapeutic cancer immunotherapy (ELI-002 7P vaccine), with or without Tislelizumab, in patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC).

The researchers are doing this study to find out whether ELI-002 7P in combination with mFOLFIRINOX, with or without tislelizumab, is a safe treatment approach in people who have pancreatic ductal adenocarcinoma (PDAC) with a KRAS mutation. In addition, the researchers are doing this study to find out whether the study treatment is effective against PDAC.

Registro actualizado en ClinicalTrials.gov →

• - Documentation of Disease
• Pathologically confirmed adenocarcinoma of the pancreas.
• Presence of one of seven KRAS mutations: G12D, G12V, G12R, G12C, G12A, G12S, or G13D.
• Definition of Disease
• Patients must have resectable or borderline resectable localized disease as defined by NCCN Guidelines v2.2025. Staging CT or MRI of the chest/abdomen/pelvis at enrollment must be negative for metastatic disease.
• Up to 4 doses of neoadjuvant mFOLFIRINOX are allowed prior to enrollment. Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.