This study focuses on people who have been diagnosed with metastatic pancreatic ductal adenocarcinoma with a specific change (mutation) in the KRAS gene. The purpose of the study is to determine the safety and effectiveness of an experimental drug called VS-7375 in treating metastatic KRAS G12D-mutated pancreatic cancer when given alone or in combination with the standard treatment, cetuximab. KRAS is a gene that can develop specific changes, which can lead to uncontrolled cell growth and cancer. One common mutation in KRAS is called G12D; to participate in this study, the change in the KRAS gene must be G12D. VS-7375 is a drug that is specifically developed to target the G12D mutation in KRAS. Cetuximab is a targeted therapy that is approved by the U.S. Food and Drug Administration (FDA). Researchers aim to determine the best dose of VS-7375, any side effects, and how many patients benefit while taking the drug. Another goal of the study is to evaluate whether VS-7375 will provide a treatment benefit to patients with metastatic pancreatic ductal adenocarcinoma that have a KRAS G12D mutation. Study procedures include blood and urine sample lab collection, electrocardiograms, echocardiograms, imaging scans, biopsies, and drug administration.
VS-7375-201: A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D Inhibitor, as Monotherapy and with Cetuximab, in Patients with Metastatic KRAS G12D-Mutated Pancreatic Cancer