Loading clinical trials...

Study of Perioperative NP137 and FOLFIRINOX in Resectable Pancreatic Cancer | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

Study of Perioperative NP137 and FOLFIRINOX in Resectable Pancreatic Cancer

A Pilot Study of Perioperative NP137 and FOLFIRINOX in Resectable Pancreatic Cancer

NCT06203821•Aram Hezel

Summary

The objective of this study is to investigate whether adding the study drug, NP137, to a patient's treatment regimen (before surgery and in combination with chemotherapy afterward) can alter the behavior of pancreatic cancer..

Detailed Description

The aim of this study is to evaluate the mechanism of action for a novel anti-Netrin-1 antibody (NP137) in patients with pancreatic ductal adenocarcinoma. Pre-clinical data indicates that anti-Netrin-1 therapy can prevent/delay metastatic progression of disease by inducing cancer cell death through its dependence receptor Unc5b as well as prevent epithelial to mesenchymal transition (EMT). This pilot study is designed to provide vital translational scientific information that will inform the design of future clinical trials for NP137. This information includes determining the optimal use of NP137 with cytotoxic, as well as the treatment setting of resectable pancreatic cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+2 more criteria

Exclusion Criteria

•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 \[CHF\],
+5 more criteria

Locations (1)

University of Rochester

Rochester, New York, United States

Key Dates

Start Date

September 1, 2026

Primary Completion Date

May 30, 2027

Completion Date

September 30, 2032

Last Updated

February 5, 2026

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

NP137

DRUG

Contacts

Aram Hezel

CONTACT

585-275-5863 aram_hezel@urmc.rochester.edu

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

RECRUITINGPHASE1/PHASE2

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

NCT05053971

Advanced Malignant Solid NeoplasmLocally Advanced Pancreatic Carcinoma+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Perioperative NP137 and FOLFIRINOX in Resectable Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing A New Anti-cancer Drug Combination, Entinostat and ZEN003694, for Advanced and Refractory Solid Tumors

Resilience and Equity in Aging, Cancer, and Health (REACH)

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

PurIST Classification-Guided Adaptive Neoadjuvant Chemotherapy by RNA Expression Profiling of EUS Aspiration Samples

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients