A Pilot Study of Neoadjuvant mFOLFIRINOX and ELI002-7P Treatment With or Without Tislelizumab in Borderline and Resectable Pancreatic Ductal Adenocarcinoma
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.
∙ \- 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.
‣ Prior Treatment
• 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
• 1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2), alopecia, and other toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator).
⁃ Age ≥18 years.
⁃ ECOG Performance Status 0-1
⁃ Pregnancy and Nursing
• Not pregnant or breastfeeding.
• Evidence of post-menopausal status or a negative urinary or serum pregnancy test for females of child-bearing potential within 28 days prior to initiation of treatment.
‣ Required Organ Function
⁃ Hematologic function:
• ANC ≥1,500/mm³
• Platelets ≥100,000/mm³
• Hemoglobin ≥8.0 g/dL
‣ Renal function:
• Creatinine clearance ≥50 mL/min (Cockcroft-Gault formula or 24-hour urine collection).
‣ Hepatic function:
• Total bilirubin ≤1.5 × ULN (Gilbert's syndrome allowed up to ≤3 × ULN)
• AST and ALT ≤3 × ULN Albumin: ≥2.5 g/dL
‣ Cardiac function: Patients with known cardiac disease or prior exposure to cardiotoxic agents should undergo risk assessment per NYHA classification; patients must be class or better. Compliance and Life Expectancy
⁃ Patient is willing and able to comply with protocol procedures, treatment, and follow-up.
• Estimated life expectancy of at least 12 weeks per treating physician.
‣ Comorbid Conditions
• No active infection requiring parenteral antibiot ic(s)
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
‣ Allergies: No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).
⁃ Concomitant Medications
• Concomitant medication use should only exclude patients when clinically relevant drug-drug interactions or overlapping toxicities are expected to impact safety or efficacy. All concomitant medications from 7 days prior to screening through 12 weeks after the last dose of investigational product must be documented in the medical record.
‣ Contraception Requirements
• Patients of reproductive potential must use highly effective contraception from screening through 90 days after the last dose of immunotherapy.