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NCT Number: NCT07026279

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pancreatic Cancer Metastatic Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GenesisCare, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

narmafotinib ascending doses

Drug

once daily capsules

narmafotinib dose comparison

Drug

once daily capsules

Primary outcomes

  1. 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

    TEAEs during study treatment and follow up periods

  2. Part B: identification of optimal dose of narmafotinib

    Time frame: From 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

Secondary outcomes

  1. narmafotinib levels in plasma

    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)

    Measurement of maximum concentration (Cmax) of narmafotinib

  2. narmafotinib levels in plasma

    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)

    Measurement of time to Cmax (tmax) of narmafotinib

  3. narmafotinib levels in plasma

    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)

    Measurement of clearance of narmafotinib

  4. Overall response rate (ORR)

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

    ORR based on RECIST 1.1

  5. Overall survival (OS)

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

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

  6. Progression free survival (PFS)

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

    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)

  7. Clinical benefit rate (CBR)

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

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

  8. Duration of response (DOR)

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

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

  9. Disease control rate (DCR)

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

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

Sponsors and collaborators

Lead sponsor

Amplia Therapeutics Limited

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 18, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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