Phase 1 Study of BBO-8520 Alone and with Pembrolizumab or BBO-10203 in Adults with Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating the safety, tolerability, pharmacokinetics, and early antitumor activity of BBO-8520, a KRAS G12C ON and OFF inhibitor, in adults with locally advanced, unresectable, or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. This Phase 1 open-label study aims to understand how BBO-8520 works alone and in combination with pembrolizumab and BBO-10203 in this patient population. Participants will receive BBO-8520 orally once daily at various dose levels. Some groups will receive BBO-8520 alone, while others will receive it combined with pembrolizumab infusions andor BBO-10203, also given orally once daily. The study includes dose escalation phases to find appropriate doses and dose expansion phases to further evaluate treatment effects. During the study, participants will be closely monitored for adverse events and dose-limiting toxicities over approximately three years. Researchers will assess preliminary antitumor activity, pharmacokinetics, and overall survival. Evaluations will include clinical assessments and safety monitoring to understand the treatments effects and tolerability throughout the study period.

Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer