Phase 2 Study Evaluating Oral VS-7375 Alone and With Cetuximab for Metastatic Pancreatic Cancer with KRAS G12D Mutation

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the oral drug VS-7375 alone and combined with the drug cetuximab in patients who have metastatic pancreatic cancer with a specific KRAS G12D mutation. This Phase 2 clinical trial focuses on understanding how well these treatments work and their safety profiles in this particular group of patients. Participants may receive VS-7375 by mouth either alone or with cetuximab given as a subcutaneous infusion. The study includes different groups where participants receive either VS-7375 alone, VS-7375 plus cetuximab as a second-line treatment, or VS-7375 plus cetuximab as a first-line treatment. The trial involves random assignment to these groups and includes a crossover design. During the study, participants will be monitored for their tumor response using imaging reviewed by an independent central team according to RECIST criteria. Safety and tolerability of the treatments will also be assessed over six months. Additional evaluations include measuring drug levels in the blood, tumor markers, quality of life through questionnaires, and timing until the next therapy. The trial is expected to continue until December 2028.

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer