Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Sponsored by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
About this study
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 and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.
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 and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation. The study includes dose escalation phase and dose expansion phase
Where this study is enrolling
- Call 855-827-9525
Oncology Consultants Texas Medical Center
Houston, Texas
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Who can participate
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 or unstable 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
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Trial data sourced from ClinicalTrials.gov.