RecruitingPhase 1NCT06343402

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

Sponsor

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

Enrollment

350 participants

Start Date

May 22, 2024

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests BBO-8520, a new oral drug targeting a specific cancer-driving mutation called KRAS G12C, in patients with advanced non-small cell lung cancer who have this mutation. Some parts of the study also combine BBO-8520 with pembrolizumab (an immunotherapy). **You may be eligible if...** - You are an adult with locally advanced, unresectable, or metastatic non-small cell lung cancer - Your tumor has the KRAS G12C mutation (confirmed by testing) - You have measurable disease - You are in generally good health (ECOG 0–1) **You may NOT be eligible if...** - You have had another cancer in the past 2 years - You have untreated brain metastases - You have a known allergy to BBO-8520 or pembrolizumab - You have active autoimmune disease (for cohorts combining with pembrolizumab) - You have a history of serious lung inflammation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBBO-8520

Participants will receive assigned dose of BBO-8520 orally (PO), QD

DRUGPembrolizumab

Patients will receive IV pembrolizumab

DRUGBBO-10203

Participants will receive assigned dose of BBO-8520 orally (PO), QD

Locations(32)

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

Roswell Park Cancer Institute

Buffalo, New York, United States

Perlmutter Cancer Center - NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

USOR - Oncology Associates of Oregon, P.C

Eugene, Oregon, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

Oncology Consultants Texas Medical Center

Houston, Texas, United States

USOR - Texas Oncology - (DFW) Waco

Waco, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

NEXT Oncology

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Peninsula & South Eastern Hematology and Oncology Group (PAS)

Frankston, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

Juravinski Cancer Centre

Hamilton, Ontario, Canada

The Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Hospital Universitario Quirónsalud Madrid

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06343402

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