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RECRUITING
NCT07026279
PHASE1/PHASE2

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

Sponsor: Amplia Therapeutics Limited

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

67

Start Date

2025-08-18

Completion Date

2029-07

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

DRUG

narmafotinib ascending doses

once daily capsules

DRUG

narmafotinib 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