Back to search results

Study of NP137 and FOLFIRINOX for Resectable Pancreatic Cancer

This study is looking at whether adding NP137 to a standard chemotherapy called FOLFIRINOX can change how pancreatic cancer cells behave. You might be able to join if you have pancreatic cancer that doctors believe can be removed with surgery, and you don't have clear signs of the cancer spreading. You would need to agree to a biopsy (taking a small tissue sample) for diagnosis and research. The main goal is to see if NP137 can make the cancer cells less aggressive, specifically by changing a feature called Epithelial-to-Mesenchymal Transition (EMT). This change would be checked 3-5 years after treatment. The study is currently recruiting participants.

Study design
This is an interventional study with a planned enrollment of 25 participants. It aims to understand how NP137 works when combined with FOLFIRINOX.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 3-5 years, suggesting a follow-up period of at least that long.

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

NCT06203821

Study of Perioperative NP137 and FOLFIRINOX in Resectable Pancreatic Cancer

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Aram Hezel
~25 participants
Updated 2026-02-05 on ClinicalTrials.gov
What's tested:NP137

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determining if NP137 can shift the primary tumor MAK's Signature Epithelial-to-Mesenchymal Transition (EMT) Mean Score towards a more epithelial phenotype
Measured over 3-5 years

Conditions

Pancreatic Cancer

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT06203821

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Rochester

    Rochester, New Yorkstudy coordinator listed

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

  • Aram Hezel · PRINCIPAL_INVESTIGATOR · University of Rochester

Who to contact

Aram Hezel
[email protected]
585-275-5863
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Subjects with imaging suggesting resectable pancreatic cancer and without strong evidence of metastatic disease.
Accept to undergo biopsy for initial diagnosis and research purposes. NOTE: For patients who already have cytologically or histologically confirmed resectable pancreatic ductal adenocarcinoma, they must agree to undergo research biopsy.
Cytologically or histologically confirmed resectable pancreatic ductal adenocarcinoma.
Confirmed resectable pancreatic ductal adenocarcinoma by treating surgeon.
No prior systemic therapy, radiation therapy, or resection for pancreatic cancer.
Written informed consent to participate in the trial.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 and ability to undergo perioperative systemic therapy, radiation therapy and surgery as deemed by the treating investigator.
Adequate bone marrow and organ function
Subjects of childbearing potential must have a negative urine or serum pregnancy test prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required for enrollment.
Subjects of child-bearing potential must agree to use adequate contraception E.g. hormonal , barrier method of birth control, and abstinence prior to study entry, for the duration of study treatment, and for 6 months after completion of study therapy. Subject who become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study therapy, subjects should agree to discontinue breastfeeding prior enrollment in the study.
As determined by the enrolling physician or protocol designee, ability of the subject to understand a written informed consent document, and ability and willingness to comply with study procedures for the entire length of the study. Patients with impaired decision-making capacity (IDMC) who have a close caregiver or legally authorized representative (LAR) and/or family member who can make may decision on the patient behalf may enroll in the trial per the enrolling physician assessment.

Exclusion

Patients with borderline or locally advanced or metastatic pancreatic cancer as deemed by treating surgeon.
Patients who are unlikely to undergo surgery, and systemic therapy, in the opinion of the treating investigators.
Patients with grade ≥ 2 peripheral neuropathy.
Patients with known Gilbert's Syndrome, Dihydropyrimidine dehydrogenase (DPD) deficiency, or homozygosity for UGAT1A1\*28 polymorphism. Note: evaluation for these is not required.
Patients with active duodenal or gastric ulcers, or direct tumor invasion of the bowel or stomach by endoscopic evaluation. Note: patients with previous ulcers without active bleeding or symptoms are eligible.
Patients with serious active infection within 2 weeks prior to enrollment (e.g. requiring hospitalization and/or intravenous \[IV\] antibiotics) or currently receiving oral or IV antibiotics for the treatment of infection. Patients receiving prophylactic antibiotics are eligible.
Patients with known untreated hepatitis B or C (HBV/HCV) or known human immunodeficiency virus (HIV). Note: evaluation for these is not required.
Patients with uncontrolled intercurrent illness within 3 months prior to start of study treatment that could substantially increase risk of incurring AEs in the opinion of the treating investigator, including but not limited to:
Uncontrolled hypertension, despite optimal medical management, hypertensive crisis, or hypertensive encephalopathy,
Symptomatic congestive heart failure \[CHF\],
Uncontrolled cardiac arrhythmia, or
Current psychiatric illness/social situations or other conditions that would limit compliance with study requirements or.
Patients with known concurrent malignancy that is expected to require active treatment within two years or may interfere with the interpretation of the efficacy and safety outcomes of this study in the opinion of the treating investigator. Note: Superficial bladder cancer, nonmelanoma skin cancers, and low-grade prostate cancer not requiring cytotoxic therapy should not exclude participation in this trial. Patients with CLL may be enrolled if they do not require active chemotherapy and their hematologic, renal and hepatic function meets criteria previously mentioned.
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications in the opinion of the treating investigator.
Pregnant or breastfeeding women

What this trial measures

  • Determining if NP137 can shift the primary tumor MAK's Signature Epithelial-to-Mesenchymal Transition (EMT) Mean Score towards a more epithelial phenotype3-5 years

    EMT score is determined by the mean expression of mesenchymal genes minus the mean expression of epithelial genes Therefore, a positive EMT score suggests a mesenchymal status (worse outcome), whereas a negative score indicates an epithelial status (better outcome).