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Active, not recruitingNCT07026279Updated May 5, 2026

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

A Phase 1/2 interventional study of narmafotinib ascending doses and narmafotinib dose comparison in Pancreatic Cancer Metastatic, sponsored by Amplia Therapeutics Limited. Active, not recruiting at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by Amplia Therapeutics Limited · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
67
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Pancreatic Cancer Metastatic

Keywords

  • pancreatic cancer
  • PDAC
  • Pancreatic Ductal Adenocarcinoma
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 67 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Amplia Therapeutics Limited is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
67 participants (estimated)

Study arms

  • Experimental
    Part A

    Part 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.

    Drug: narmafotinib ascending doses

  • Experimental
    Part B

    Part B will determine the efficacy of 2 doses of narmafotinib selected from Part A

    Drug: narmafotinib dose comparison

Interventions

  • Drugnarmafotinib ascending doses

    once daily capsules

  • Drugnarmafotinib dose comparison

    once daily capsules

06

What researchers measure

Primary outcomes

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

    TEAEs during study treatment and follow up periods

    Time frame: 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

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

Secondary outcomes

  1. narmafotinib levels in plasma

    Measurement of maximum concentration (Cmax) of narmafotinib

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

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

07

Study locations

2 sites
  • GenesisCare
    St Leonards, New South Wales 2065, Australia
  • Epworth Healthcare
    Richmond, Victoria 3121, Australia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07026279
Lead sponsor
Amplia Therapeutics Limited
Responsible party
Sponsor
First posted
Jun 18, 2025
Start date
Aug 18, 2025
Primary completion
Jul 2029 (estimated)
Completion
Jul 2029 (estimated)
Last update
May 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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