James Gulley, MD, PhD, FACP, on Assessing a Novel TCR Bifunctional Antibody in CPI-Resistant Solid Tumors

“We have very interesting preclinical data showing that across a wide range of different tumor types in murine models, we get good single agent activity. And what we also see is that there's a broadening of that immune response. So, what we've done now is we've taken this and started our first-in-human study that's open at the National Cancer Institute, as well as at Mass General Hospital.”

Thephase 1/2 START-001 trial (NCT05592626) is assessing intravenous infusion of STAR0602 once every 2 weeks in patients with checkpoint inhibitor (CPI)-resistant solid tumors. The phase 1 portion is a dose escalation through 8 provisional dose levels. STAR0602 is a first-in-class, TCR β chain-targeting bifunctional antibody fused to a costimulatory molecule that binds the germline Vβ6/Vβ10 TCRs of human alpha/beta (aβ) T cells, and promotes the selective activation and expansion of CD8+ and CD4+ Vβ6/Vβ10 effector memory T cells by simultaneously engaging direct T-cell receptor activation with IL-2 receptor binding and activation. The study began enrolling in January 2023.

James Gulley, MD, PhD, FACP, director of the Medical Oncology Service at the National Cancer Institute, presented the trial design at the 2023 American Society of Clinical Oncology (ASCO) meeting, held June 2-6, 2023, held both virtually and in Chicago, Illinois.

CGTLive™’s sister site, OncLive™, spoke with Gulley to learn more about STAR0602 and its potential advantages in treating solid tumors resistant to checkpoint inhibitors. He discussed how this mode of therapy could potentially change the treatment landscape and shared his hopes that STAR0602 will prove to be efficacious in the trial.

Click here for more coverage of ASCO 2023.

REFERENCE

Sullivan RJ, Redman JM, Tschernia N, et al.Trial START-001: A phase 1/2 study of STAR0602, a first-in-class, selective T cell receptor (TCR)-targeting, bifunctional antibody-fusion molecule, as monotherapy in patients with antigen-rich tumors post checkpoint inhibitor (CPI) treatment. Presented at: 2023 ASCO Meeting; June 2-6; Chicago, Illinois. Poster #509a