This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Who can Participate

Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov Inclusion Criteria: Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation Measurable disease by RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Exclusion Criteria: Patients with malignancy within the last 2 years as specified in the protocol Patients with untreated brain metastases Patients with known hypersensitivity to BBO-8520 or its excipients For Cohorts 1b and 2b: Patients with a known hypersensitivity to pembrolizumab or its excipients Patients with active autoimmune disease of history of autoimmune disease that might recur Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis Other inclusion/exclusion criteria may apply

Study ID

More information available at ClinicalTrials.gov: NCT06343402