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RecruitingNon-small Cell Lung CancerMetastatic Non-Small Cell Lung CancerNSCLC

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

Eligible age

18+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

No

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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.

Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

You may qualify if…

  • 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

You may not qualify if…

  • 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

Where it's recruiting

Alabama

Birmingham

California

La Jolla · San Francisco · Santa Monica

Colorado

Aurora

Connecticut

New Haven · Norwalk

Illinois

Peoria

Kansas

Kansas City

Michigan

Detroit

New York

Buffalo · New York

Ohio

Cleveland

Oregon

Eugene

Tennessee

Nashville

Texas

Houston · Waco

Source: ClinicalTrials.gov · NCT06343402 · last updated 2026-05-05