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ELI-002 7P with or without Tislelizumab for Pancreatic Cancer

This study is looking at ELI-002 7P, an immunotherapy, in combination with standard chemotherapy (mFOLFIRINOX), and sometimes with another drug called Tislelizumab. These treatments are given to people with pancreatic cancer that can be removed by surgery or is borderline resectable. The main goal is to see how safe these treatments are, specifically looking at serious side effects. Researchers also want to see if the treatments are effective against pancreatic cancer. You might be able to join if you have pancreatic adenocarcinoma with specific changes (mutations) in the KRAS gene, such as G12D or G12V. The study plans to enroll 20 participants.

Study design
This is an open-label study, meaning you and your doctors will know which treatments you are receiving. It is a pilot study involving multiple institutions.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track drug-related side effects for up to 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07671339

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~20 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:ELI-002 7PTislelizumabmFOLFIRINOX

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
the proportion of patients with a Grade 3 or higher drug-related adverse event (AE)
Measured over 2 years

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic AdenocarcinomaGTPase KRas

NCT07671339

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activites)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kevin Soares, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Kevin Soares, MD
[email protected]
212-639-3195
Email the study team

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Eligibility criteria

Inclusion

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
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.

Exclusion

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.

What this trial measures

  • the proportion of patients with a Grade 3 or higher drug-related adverse event (AE)2 years

    according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0