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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.
