Pancreatic CancerPhase 1NCT07671339
A Study of ELI-002 7P, With or Without Tislelizumab, in People With Pancreatic Cancer
A Phase 1 study testing ELI-002 7P, Tislelizumab and mFOLFIRINOX in people with Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- ELI-002 7P, Tislelizumab and mFOLFIRINOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 7 sitesUnited States
- Study dates
- 22 Jun 2026to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eileen O'Reilly, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Kevin Soares, MD, 212-639-3195
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Kevin Soares, MD, 212-639-3195
About this study
Official title: 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.
Read the detailed description
This is an open-label, multi-institution pilot study of neoadjuvant mFOLFIRINOX (5-Fluorouracil, oxaliplatin, leucovorin, irinotecan) and a lipid-conjugated Kristin-Ras (KRAS) therapeutic cancer immunotherapy (ELI-002 7P vaccine), with or without Tislelizumab, in patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC).
- Conditions
- Pancreatic Cancer
- Being tested
- ELI-002 7P, Tislelizumab, mFOLFIRINOX
- Keywords
- ELI-002 7P, Tislelizumab, 25-386
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELI-002 7PDrug
a subcutaneous (SC) injection under the skin
TislelizumabDrug
s an intravenous (IV) infusion
mFOLFIRINOXDrug
neoadjuvant mFOLFIRINOX (5-Fluorouracil,oxaliplatin, leucovorin, irinotecan)
| Study group | Role | What they receive |
|---|---|---|
| ELI-002 7P concurrent with mFOLFIRINOX | Active comparator | Participants receives ELI-002 7P during adjuvant chemotherapy. Receives: Drug: ELI-002 7P; Drug: mFOLFIRINOX |
| Tislelizumab in addition to ELI-002 7P and mFOLFIRINOX. | Experimental | Participants will receive Ttislelizumab IV every four weeks concurrent with ELI-002 7P. Receives: Drug: ELI-002 7P; Drug: Tislelizumab; Drug: mFOLFIRINOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start22 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- BeOne Medicines, Breakthrough Cancer, Elicio Therapeutics, Lustgarten Foundation
- Responsible party
- Sponsor
- Investigators
- Kevin Soares, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671339
- Sponsor's protocol ID
- 25-386
- Status last verified
- Oct 2026
- First submitted
- 22 Jun 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neoadjuvant mFOLFIRINOX and ELI002-7P Treatment With or Without Tislelizumab in Borderline and Resectable Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07671339
- Acronym / sponsor ID
- 25-386
- Conditions
- Pancreatic Cancer
- Keywords
- ELI-002 7P, Tislelizumab, 25-386
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- BeOne Medicines, Breakthrough Cancer, Elicio Therapeutics, Lustgarten Foundation
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, multi-institution pilot study of neoadjuvant mFOLFIRINOX (5-Fluorouracil, oxaliplatin, leucovorin, irinotecan) and a lipid-conjugated Kristin-Ras (KRAS) therapeutic cancer immunotherapy (ELI-002 7P vaccine), with or without Tislelizumab, in patients diagnosed with resectable or borderline resectable pancreatic ductal adenocarcinoma (PDAC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELI-002 7P concurrent with mFOLFIRINOX | Active comparator | Drug: ELI-002 7P, Drug: mFOLFIRINOXParticipants receives ELI-002 7P during adjuvant chemotherapy. |
| Tislelizumab in addition to ELI-002 7P and mFOLFIRINOX. | Experimental | Drug: ELI-002 7P, Drug: Tislelizumab, Drug: mFOLFIRINOXParticipants will receive Ttislelizumab IV every four weeks concurrent with ELI-002 7P. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Documentation of Disease
- Pathologically confirmed adenocarcinoma of the pancreas.
- Presence of one of seven KRAS mutations: G12D, G12V, G12R, G12C, G12A, G12S, or G13D.
- 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.
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELI-002 7Pa subcutaneous (SC) injection under the skin | Drug | ELI-002 7P concurrent with mFOLFIRINOX, Tislelizumab in addition to ELI-002 7P and mFOLFIRINOX. |
| Tislelizumabs an intravenous (IV) infusion | Drug | Tislelizumab in addition to ELI-002 7P and mFOLFIRINOX. |
| mFOLFIRINOXneoadjuvant mFOLFIRINOX (5-Fluorouracil,oxaliplatin, leucovorin, irinotecan) | Drug | ELI-002 7P concurrent with mFOLFIRINOX, Tislelizumab in addition to ELI-002 7P and mFOLFIRINOX. |
Primary outcome
the proportion of patients with a Grade 3 or higher drug-related adverse event (AE)
Time frame: 2 years
according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eileen O'Reilly, MD contact
Kevin Soares, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ELI-002 7P, Tislelizumab and mFOLFIRINOX in people with Pancreatic Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 34 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Soares, MD (212-639-3195, soaresk@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients with a Grade 3 or higher drug-related adverse event (AE) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.