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

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.