Recruiting
Phase 1
Phase 2

Narmafotinib with mFOLFIRINOX

Sponsor:

Amplia Therapeutics Limited

Code:

NCT07026279

Conditions

Pancreatic Cancer Metastatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

narmafotinib ascending doses

narmafotinib dose comparison

Study Details

Brief 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.

Conditions

Pancreatic Cancer Metastatic

Study ID

NCT07026279

Start date

Aug 18, 2025

Status verified date

Feb, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

67 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

experimental: Part B

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

Interventions

narmafotinib ascending doses

once daily capsules

narmafotinib dose comparison

once daily capsules

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Director, Clinical Operations

+61 3 9123 1140info@ampliatx.com

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Canceranswer@ccf.org

More Information

Sponsor

Amplia Therapeutics Limited

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • pancreatic cancer
  • PDAC
  • Pancreatic Ductal Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Amplia Therapeutics Limited on 2026-02-23.