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New drug combo aims to outsmart pancreatic cancer before surgery

NCT ID NCT06203821

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial will test whether adding the study drug NP137 to standard chemotherapy (FOLFIRINOX) can change the behavior of pancreatic cancer cells before and after surgery. About 25 people with resectable pancreatic cancer will receive the combination, and researchers will look for signs that the tumor becomes less aggressive. The goal is to see if this approach is safe and might help prevent the cancer from coming back or spreading.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NP137 (a study drug) plus FOLFIRINOX chemotherapy
What this could lead to
If it works, this could point toward a new treatment approach for pancreatic cancer that may help control the disease and reduce the chance of it spreading.
What could go wrong
This is a very early Phase 1 trial with only 25 people, so it is primarily testing safety and feasibility. The drug may not work as hoped, and side effects from the combination could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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 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 \[CHF\], * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Rochester

    Rochester, New York, 14642, United States

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Other studies related to the condition(s) this trial covers.