RecruitingPhase 1Phase 2NCT07026279

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

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

Sponsor

Amplia Therapeutics Limited

Enrollment

67 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Metastatic

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new targeted drug called narmafotinib in combination with a standard chemotherapy regimen (modified FOLFIRINOX) as a first-line treatment for patients with metastatic pancreatic cancer (cancer that has spread beyond the pancreas). **You may be eligible if...** - You are 18 or older - You have recently been diagnosed with metastatic pancreatic adenocarcinoma (within the past 6 weeks) and have not yet received treatment - Your cancer is measurable on imaging - You are in good health (ECOG 0–1) with a life expectancy over 3 months - You are eligible for standard FOLFIRINOX chemotherapy - You agree to use effective contraception **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have neuroendocrine or acinar cell pancreatic tumors (a different type) - You have brain metastases - You previously received chemotherapy for metastatic disease - You have HIV, active hepatitis B or C, or significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGnarmafotinib ascending doses

once daily capsules

DRUGnarmafotinib dose comparison

once daily capsules

Locations(7)

UC Irvine Chao Family Cancer Centre

Orange, California, United States

University of Florida Shands

Gainesville, Florida, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Vanderbilt University Medical Centre

Nashville, Tennessee, United States

GenesisCare

St Leonards, New South Wales, Australia

Epworth Healthcare

Richmond, Victoria, Australia

View Full Details on ClinicalTrials.gov

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NCT07026279

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