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Pancreatic Cancer MetastaticPhase 1/2NCT07026279

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

A Phase 1/2 study testing narmafotinib ascending doses and narmafotinib dose comparison in people with Pancreatic Cancer Metastatic, run by Amplia Therapeutics Limited at 2 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is testing narmafotinib, a type of drug called a focal adhesion kinase (FAK) inhibitor, when it is given in combination with 4 chemotherapy drugs in a regimen called FOLFIRINOX, to patients who have pancreatic cancer which has metastasised (spread). The study is being run in 2 parts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer Metastatic
What is being tested?
narmafotinib ascending doses and narmafotinib dose comparison
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
2 sitesAustralia
Study dates
18 Aug 2025to Jul 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • Epworth Healthcare

    Richmond, Victoria, 3121

  • GenesisCare

    St Leonards, New South Wales, 2065

Other trials in Australia

About this study

Official title: A Phase 1b/2a, Multicenter, Open Label Study of the Safety, Efficacy and Pharmacokinetics of Narmafotinib in Combination With Modified FOLFIRINOX in Pancreatic Cancer Patients

This study is testing narmafotinib, a type of drug called a focal adhesion kinase (FAK) inhibitor, when it is given in combination with 4 chemotherapy drugs in a regimen called FOLFIRINOX, to patients who have pancreatic cancer which has metastasised (spread). The study is being run in 2 parts.

Part A will test increasing dose levels of narmafotinib in at least 3 people per dose at up to 4 dose levels to assess safety.

Read more

Part B will test 2 of the dose levels from Part A in 20 people per dose, to select the best dose to take forward into future studies.

Participants will take narmafotinib as oral capsules every day. They will also receive mFOLFIRINOX chemotherapy on Day 1 and and Day 15 of 28-day cycles.

Being tested
narmafotinib ascending doses, narmafotinib dose comparison
Keywords
pancreatic cancer, PDAC, Pancreatic Ductal Adenocarcinoma
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • narmafotinib ascending dosesDrug

    once daily capsules

  • narmafotinib dose comparisonDrug

    once daily capsules

Study groups in NCT07026279
Study groupRoleWhat they receive
Part AExperimentalPart A is a phase 1b dose-escalation design that will enrol at least 3 participants in each of 4 dose-level cohorts, to determine 2 doses of narmafotinib to be explored in Part B.
Receives: Drug: narmafotinib ascending doses
Part BExperimentalPart B will determine the efficacy of 2 doses of narmafotinib selected from Part A
Receives: Drug: narmafotinib dose comparison

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study

    TEAEs during study treatment and follow up periods

    Measured: From first dose of study drug to end of study, an expected average of 6 months

  2. Part B: identification of optimal dose of narmafotinib

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

    Measured: From first dose of study drug to end of study, an expected average of 6 months

Secondary outcomes (9)

  1. narmafotinib levels in plasma

    Measurement of maximum concentration (Cmax) of narmafotinib

    Measured: Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days)

  2. narmafotinib levels in plasma

    Measurement of time to Cmax (tmax) of narmafotinib

    Measured: Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days)

  3. narmafotinib levels in plasma

    Measurement of clearance of narmafotinib

    Measured: Days -7, -6, -1, 1 and 15 of Run-In/Cycle 1; and Day 1 of Cycles 2 and 4 (each cycle is 28 days)

  4. Overall response rate (ORR)

    ORR based on RECIST 1.1

    Measured: Imaging every 56 days per participant, with an expected average duration of 6 months

  5. Overall survival (OS)

    OS of participants, defined as time from first dose until death from any cause

    Measured: Imaging every 56 days per participant, with an expected average duration of 6 months

  6. Progression free survival (PFS)

    PFS of participants, defined as time from first dose to date of first observed progression, based on RECIST, or death from any cause (whichever comes first)

    Measured: Imaging every 56 days per participant, with an expected average duration of 6 months

  7. Clinical benefit rate (CBR)

    CBR defined as the proportion of patients with complete response (CR) + partial response (PR) + stable disease (SD) with SD for at least 6 months

    Measured: Imaging every 56 days per participant, with an expected average duration of 6 months

  8. Duration of response (DOR)

    DOR based on RECIST defined as the time from the date of the first confirmed response to the date of progression or death

    Measured: Imaging every 56 days per participant, with an expected average duration of 6 months

  9. Disease control rate (DCR)

    DCR based on RECIST defined as the proportion of participants who achieve complete response (CR), partial response (PR) or stable disease (SD)

    Measured: Imaging every 56 days per participant, with an expected average duration of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start18 Aug 2025
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Part A - dose ascending BOIN design Part B - parallel arm (2 dose levels)
Masking
None (open label)
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07026279
Sponsor's protocol ID
AMP945-PC-202
Other IDs
U1111-1298-5990
Status last verified
Apr 2026
First submitted
29 Apr 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing narmafotinib ascending doses and narmafotinib dose comparison in people with Pancreatic Cancer Metastatic, run by Amplia Therapeutics Limited at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study (time frame: From first dose of study drug to end of study, an expected average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07026279.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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