A Study of ELI-002 7P, With or Without Tislelizumab, in People With Pancreatic Cancer
A Pilot Study of Neoadjuvant mFOLFIRINOX and ELI002-7P Treatment With or Without Tislelizumab in Borderline and Resectable Pancreatic Ductal Adenocarcinoma
1 other identifier
interventional
20
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pancreatic-cancer
Started Jun 2026
Shorter than P25 for phase_1 pancreatic-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2026
CompletedStudy Start
First participant enrolled
June 22, 2026
CompletedFirst Posted
Study publicly available on registry
June 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
June 26, 2026
June 1, 2026
1.9 years
June 22, 2026
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 years
Study Arms (2)
ELI-002 7P concurrent with mFOLFIRINOX
ACTIVE COMPARATORParticipants receives ELI-002 7P during adjuvant chemotherapy.
Tislelizumab in addition to ELI-002 7P and mFOLFIRINOX.
EXPERIMENTALParticipants will receive Ttislelizumab IV every four weeks concurrent with ELI-002 7P.
Interventions
a subcutaneous (SC) injection under the skin
s an intravenous (IV) infusion
neoadjuvant mFOLFIRINOX (5-Fluorouracil,oxaliplatin, leucovorin, irinotecan)
Eligibility Criteria
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
- (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:
- +19 more criteria
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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- BeOne Medicinescollaborator
- Breakthrough Cancercollaborator
- Elicio Therapeuticscollaborator
- Lustgarten Foundationcollaborator
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Soares, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2026
First Posted
June 26, 2026
Study Start
June 22, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
June 26, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.