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New treatment option for Pancreatic Cancer
Official title A Study of ELI-002 7P, With or Without Tislelizumab, in People With Pancreatic Cancer
ClinicalTrials.gov ID: NCT07671339
What this study is testing
What is ELI-002 7P?
ELI-002 7P is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Locally advanced unresectable PDAC (per NCCN v2.2025), including unreconstructable venous anatomy, arterial tumor contact ≥180° (superior mesenteric...
- 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...
- 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...
See the full eligibility criteria
- \- 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...
- 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 how well it works assessment of the investigational regimen are eligible for...
- 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 how well it works. All concomitant medications from 7...
- Contraception Requirements
- Patients of reproductive potential must use highly effective contraception from screening through 90 days after the last dose of immunotherapy.
- 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...
- 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...
- Uncontrolled intercurrent illness including, but not limited to, symptomatic CHF, unstable angina, uncontrolled arrhythmia, uncontrolled hypertension, interstitial lung disease, serious GI conditions with chronic...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.