New drug combo shows promise in tough pancreatic cancer

NCT ID NCT07026279

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ยท Last updated Jun 27, 2026

Summary

This study tests a new drug called narmafotinib, taken as a daily pill, together with a standard chemotherapy regimen (mFOLFIRINOX) in people whose pancreatic cancer has spread. The trial has two parts: first, finding a safe dose, then comparing two doses in 20 people each. The goal is to see if the combination is safe and effective, and to pick the best dose for future studies.

What this could mean

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

Active substance
narmafotinib (a FAK inhibitor) combined with modified FOLFIRINOX chemotherapy
What this could lead to
If successful, this could lead to a new treatment option that helps control metastatic pancreatic cancer and improves survival.
What could go wrong
This is an early-phase trial with only 67 participants, so results may not apply to all patients. The drug combination may cause significant side effects or fail to show benefit.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 67 people

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

Started

Aug 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Aged at least 18 years at the time of consent. * Confirmed diagnosis of metastatic pancreatic adenocarcinoma (PDAC) within the 6 weeks prior to study start and have not received treatment for metastatic PDAC. * Have measurable disease by RECIST v1.1. * Eligible for treatment with mFOLFIRINOX as standard of care therapy. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 * Have a life expectancy of \> 3 months. * Adequate organ function * Agree to use effective contraception. Exclusion Criteria: * Pregnant or breast-feeding * Have received any investigational medicinal product (IMP) within 30 days or 5 half-lives (whichever is longer) prior to Day -7. * Neuroendocrine or acinar cell pancreas tumors. * Known brain metastases. * Conditions that could interfere with the swallowing or absorption of study medication. * Received previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease. * Received cytotoxic doses of any 5-FU based chemotherapy. * Any chemotherapy related toxicities greater than grade 1 from prior neoadjuvant or adjuvant therapy for PDAC. * Human immunodeficiency virus (HIV) infection and/or history of Hepatitis B infection or known to have active hepatitis B or C. * Uncontrolled angina, myocardial infarction, coronary stenting, stroke, or cerebrovascular accident within 1-year prior to the first dose of study drug. * History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis. * Clinical signs of active infection at the time of Screening or Baseline. * Clinically significant allergies to narmafotinib, mFOLFIRINOX components (or any of their excipients) that are not likely to be well controlled with pre-medication or other supportive measures. * Any of the conditions or events outlined in the Contraindications or Special Warnings and Precautions sections of the mFOLFIRINOX component package inserts. * Peripheral neuropathy \> Grade 1. * Prior treatment with narmafotinib or other FAK inhibitor within the 2 years prior to screening.

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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.

Contacts and locations

Locations

  • Epworth Healthcare

    Richmond, Victoria, 3121, Australia

  • GenesisCare

    St Leonards, New South Wales, 2065, Australia

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