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.
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.
Locally advanced unresectable PDAC (per NCCN v2.2025), including unreconstructable venous anatomy, arterial tumor contact ≥180° (superior mesenteric, celiac, or hepatic artery), or aortic invasion
Metastatic PDAC.
Prior treatment with TNF receptor agonists (OX40, CD27, CD137/4-1BB, GITR) or prior checkpoint inhibitor therapy (anti-CTLA-4, anti-PD-1, anti-PD-L1).
Active infection including tuberculosis, hepatitis A, active HBV (HBsAg+), or active HCV. Patients with resolved HBV (anti-HBc+, HBsAg-) may enroll. HCV Ab+ patients are eligible if HCV RNA PCR is negative. Successfully treated cholangitis is not exclusionary if no active infection remains.
Parallel
ELI-002 7P
Druga subcutaneous (SC) injection under the skin
Tislelizumab
Drugs an intravenous (IV) infusion
mFOLFIRINOX
Drugneoadjuvant mFOLFIRINOX (5-Fluorouracil,oxaliplatin, leucovorin, irinotecan)
the proportion of patients with a Grade 3 or higher drug-related adverse event (AE)
according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
BeOne Medicines
Collaborator
Breakthrough Cancer
Collaborator
Elicio Therapeutics
Collaborator
Lustgarten Foundation
Collaborator
