Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
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.
Checked against the public recordLast updated May 5, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Interventions being studied
- Drug: BBO-8520; Drug: Pembrolizumab; Drug: BBO-10203
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- O'Neal Comprehensive Cancer Center at UABBirmingham, Alabama
- University of California - San Diego Moores Cancer CenterLa Jolla, California
- University of California San FranciscoSan Francisco, California
- UCLA Health - Santa Monica Cancer CareSanta Monica, California
- University of Colorado Cancer CenterAurora, Colorado
- Yale Cancer CenterNew Haven, Connecticut
- Norwalk HospitalNorwalk, Connecticut
- OSF Saint Francis Medical CenterPeoria, Illinois
- University of Kansas Medical CenterKansas City, Kansas
- Henry Ford Cancer - DetroitDetroit, Michigan
- Roswell Park Cancer InstituteBuffalo, New York
- Perlmutter Cancer Center - NYU Langone HealthNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 5, 2026. Always confirm current availability with the study team.