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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBBO-8520 and Pembrolizumab

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 3, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?38 U.S. locations

Locations may change over time.

Who runs it?TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→

Biomarkers

KRAS→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

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
University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer CenterBaltimore, Maryland
Henry Ford Cancer - DetroitDetroit, Michigan
Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 3, 2026. Always confirm current availability with the study team.

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