A Study of ELI-002 7P, With or Without Tislelizumab, in People With Pancreatic Cancer

Recruiting now · Phase 1

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT07671339

Run by

Memorial Sloan Kettering Cancer Center

People needed

20

Starts

2026-06-22

Expected to finish

2028-06-01

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Known HIV infection not meeting the on-study guideline criteria above.
• Active or prior documented autoimmune/inflammatory disorders including: IBD, systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, systemic sclerosis, CNS or motor neuropathy of autoimmune origin (e.g., Guillain-Barré, myasthenia gravis, multiple sclerosis). Exceptions: vitiligo, alopecia, stable hypothyroidism on replacement, remote (>5 years) inactive autoimmune disease, or celiac disease controlled by diet.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic CHF, unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, interstitial lung disease, serious GI conditions with chronic diarrhea, or psychiatric/social situations limiting compliance.
• Current or prior systemic immunosuppressive medication within 14 days of first ELI-002 7P dose.
• Exceptions: intranasal/inhaled/topical steroids, local steroid injections, physiologic replacement doses (≤10 mg prednisone/day or equivalent), steroids as premedication for imaging contrast allergy, or limited steroid use as anti-emetic with mFOLFIRINOX.
• Receipt of a live attenuated vaccine within 30 days prior to first dose of immunotherapy.
• Pregnancy, breastfeeding, or unwillingness to use effective contraception during treatment and for 90 days after last immunotherapy dose.
• Allergy or hypersensitivity to study drugs or excipients.
• Any other malignancy within 3 years except adequately treated cervical carcinoma in situ, non-muscle-invasive bladder cancer, localized prostate cancer, or non-melanoma skin cancers.
• Prior allogeneic organ transplantation.

Where it is running

• Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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