New drug combo shows promise in tough pancreatic cancer
NCT ID NCT07026279
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 Hide 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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