An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Trial Status: active
A first in human study to evaluate the safety and preliminary antitumor activity of
BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with
pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small
cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06343402.
