Dr. Hong on the Efficiency of the CodeBreaK 101 Trial in KRAS G12C-Mutated CRC and Other Solid Tumors

David S. Hong, MD, deputy chair, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the efficiency of the ongoing phase 1/2 CodeBreaK 101 trial (NCT04185883) in KRAS G12C-mutated advanced colorectal cancer (CRC) and other solid tumors.

The CodeBreaK 101 trial is evaluating the utility of sotorasib (Lumakras) alone and in combination regimens in patients with advanced KRAS G12C-mutated CRC and other solid tumors. Although complicated, the study is efficient from a regulatory perspective because it allows for multiple arms to be tested at once without having to activate subsequent trials, Hong explains.

The study schema of CodeBreaK 101 was presented during the 2022 Gastrointestinal Cancers Symposium as a trial in progress.

It is likely that other multi-arm, phase 1 studies like CodeBreaK 101 will emerge, Hong says. However, these studies are difficult for sites to accrue to because of the number of arms that are being evaluated. As such, sites will have to determine which arms they are able to enroll patients on, Hong concludes.