Study of Avutometinib (VS-6766) +Defactinib With Gemcitabine and Nab-paclitaxel in Patients With Pancreatic Cancer

This study will assess the safety and efficacy of avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with Pancreatic Ductal Adenocarcinoma (PDAC) who have been previously untreated.

Inclusion Criteria:Male or female subjects ≥ 18 years of ageHistologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma.An Eastern Cooperative Group (ECOG) performance status ≤ 1Measurable disease according to RECIST 1.1Adequate organ functionAdequate cardiac functionAgreement to use highly effective method of contraceptiveExclusion Criteria:Patients with pancreatic neuroendocrine tumorsPrior or concomitant treatment for metastatic pancreatic ductal adenocarcinomaPrior treatment with inhibitors of the RAS /MAPK pathway [e.g. MEK inhibitors] or inhibitors of FAKHistory of prior malignancy, with the exception of curatively treated malignanciesMajor surgery within 4 weeks (excluding placement of vascular access)Concurrent heart disease or severe obstructive pulmonary diseaseConcurrent ocular disordersActive skin disorder that has required systemic therapy within the past 1 yearPatients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndromeKnown SARS-Cov2 infection ≤28 days prior to first dose of study therapy