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A Study of Narmafotinib with FOLFIRINOX for Metastatic Pancreatic Cancer

This study is testing a new drug called narmafotinib alongside a standard chemotherapy treatment called FOLFIRINOX for people with pancreatic cancer that has spread (metastatic). Narmafotinib is a type of drug called a focal adhesion kinase (FAK) inhibitor. The study will enroll 67 participants and is looking to see how safe narmafotinib is and to find the best dose to use. You would take narmafotinib as capsules every day and receive FOLFIRINOX chemotherapy on specific days of a 28-day cycle. To join, you must be at least 18 years old, have a confirmed diagnosis of metastatic pancreatic cancer within 6 weeks of the study start, and not have received prior treatment for it. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 67 participants. It has two parts: Part A tests increasing doses of narmafotinib for safety, and Part B compares two doses to select the best one.
What's involved
You would take narmafotinib capsules daily and receive mFOLFIRINOX chemotherapy on Day 1 and Day 15 of 28-day cycles. The study will last an average of 6 months from your first dose.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for treatment-emergent adverse events (side effects) from your first dose until the end of the study, which is expected to be an average of 6 months.

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

NCT07026279

A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Amplia Therapeutics Limited
~67 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:narmafotinib ascending dosesnarmafotinib dose comparison

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study
Measured over From first dose of study drug to end of study, an expected average of 6 months
+1 more outcome measured

Conditions

Pancreatic Cancer Metastatic

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NCT07026279

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Epworth Healthcare

    Richmond, Victoria, Australiano site contact published

  • GenesisCare

    St Leonards, New South Wales, Australiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of StudyFrom first dose of study drug to end of study, an expected average of 6 months

    TEAEs during study treatment and follow up periods

  • Part B: identification of optimal dose of narmafotinibFrom first dose of study drug to end of study, an expected average of 6 months

    The optimal dose will be selected based on a review of safety, pharmacokinetics (PK), pharmacodynamics (PD), efficacy, and any other available relevant data