Phase 12 Study of VS-7375, a KRAS G12D Inhibitor, Alone and Combined with Other Treatments in Adults with Advanced KRAS G12D-Mutated Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of VS-7375, an oral drug that targets the KRAS G12D mutation, in patients with advanced solid tumors that have this specific mutation. The study includes patients with pancreatic ductal adenocarcinoma, non-small cell lung cancer, colorectal cancer, and other solid tumors harboring the KRAS G12D mutation. The trial is a Phase 12, open-label study sponsored by Verastem, Inc., aiming to find suitable doses and understand the drugs impact alone and in combination with other therapies. The study has several parts dose escalation to find the best dose of VS-7375 alone and combined with cetuximab, carboplatinpemetrexedpembrolizumab, or gemcitabine-based therapies and dose expansion to evaluate the effectiveness of these treatments at the recommended doses. Treatment cycles last 21 or 28 days, and combinations are tailored for different tumor types and patient groups, including older adults. Cetuximab is an antibody targeting EGFR, while other drugs used are chemotherapy or immunotherapy agents. Participants will have regular assessments to monitor safety, side effects, and how well the treatments work over up to 2.5 years. These include measuring disease response using standard criteria, monitoring adverse events, and evaluating drug levels in the body. The study tracks tolerability and side effects during treatment and continues follow-up after treatment ends. Participants must meet specific health and tumor criteria and agree to use contraception during the study.

A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors