Study of Sotorasib for Adults With KRAS G12C Brain Tumors Undergoing Surgery Evaluating Safety, Effectiveness, and Drug Behavior in the Body

What this Trial Is About

Researchers are evaluating the effectiveness of sotorasib in treating brain tumors that have the KRAS G12C mutation. This study aims to understand how well sotorasib reaches these metastatic brain tumors during surgical removal, and to assess the safety and effectiveness of the treatment. Additionally, the study will examine how the body absorbs, distributes, and eliminates sotorasib. Participants will receive sotorasib either at the standard FDA-recommended dose or continue with their current dose as directed by their doctor. The study includes adults undergoing neurosurgical resection or biopsy of one or more brain tumors, including those with leptomeningeal metastasis if they require brain tumor surgery. There is no limit on previous radiation or systemic therapy, and treatment will follow standard care guidelines. During the study, participants will have assessments of tumor response over the course of one year, including monitoring of overall response rate. Safety and treatment effects will be closely observed through regular clinical evaluations and laboratory tests to measure blood counts, kidney and liver function, and other health parameters. The trial is non-randomized and open-label, with the Memorial Sloan Kettering Cancer Center leading the study, and participation will last as long as the treatment and follow-up periods extend.

A Study of Sotorasib in People With Brain Tumors