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

NCT ID: NCT07026279

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-18
• Study Completion Date: 2029-07-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

narmafotinib ascending doses

Intervention Type: DRUG

once daily capsules

Part B

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

Group Type: EXPERIMENTAL

narmafotinib dose comparison

Intervention Type: DRUG

once daily capsules

Interventions

narmafotinib ascending doses

once daily capsules

Intervention Type: DRUG

narmafotinib dose comparison

once daily capsules

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amplia Therapeutics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GenesisCare

St Leonards, New South Wales, Australia

Site Status: RECRUITING

Epworth Healthcare

Richmond, Victoria, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Director, Clinical Operations

Role: CONTACT

info@ampliatx.com

+61 3 9123 1140

Facility Contacts

Role: primary

referrals.northshore@genesiscare.com

Role: backup

sydneynorthresearch@genesiscare.com

Role: primary

EHjreissaticentre@epworth.org.au

Other Identifiers

U1111-1298-5990

Identifier Type: OTHER

Identifier Source: secondary_id

AMP945-PC-202

Identifier Type: -

Identifier Source: org_study_id