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Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study

NCT06343402•TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

View on ClinicalTrials.gov

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 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.

Detailed Description

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 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (31)

O'Neal Comprehensive Cancer Center at UAB

Birmingham, Alabama, United States

University of California - San Diego Moores Cancer Center

La Jolla, California, United States

University of California San Francisco

San Francisco, California, United States

UCLA Health - Santa Monica Cancer Care

Santa Monica, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Henry Ford Cancer - Detroit

Detroit, Michigan, United States

Key Dates

Start Date

May 22, 2024

Primary Completion Date

August 1, 2027

Completion Date

February 1, 2028

Last Updated

March 3, 2026

Enrollment

250

ESTIMATED participants

Conditions

Non-small Cell Lung CancerMetastatic Non-Small Cell Lung CancerNSCLCKRAS G12CMetastatic Lung CancerAdvanced Lung Carcinoma

Interventions

BBO-8520

DRUG

Pembrolizumab

DRUG

Contacts

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

CONTACT

650-405-8440 onkoras-101ct.gov@bridgebiooncology.com

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITINGPHASE3

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment