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Phase 1Recruiting

BBO-11818 in Adult Subjects With KRAS Mutant Cancer

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

About this study

A first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.

This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab + cis/carboplatin + pemetrexed, cetuximab, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.

Where this study is enrolling (16)

  • University of California San Diego Moores Cancer Center

    San Diego, California

    Call 858-822-6100

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  • The Angeles Clinic and Research Institute - West Los Angeles Office

    Los Angeles, California

    Call 310-582-7900

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  • University of California San Francisco Helen Diller Family Comprehensive Cancer Center

    San Francisco, California

    Call 415-885-7796

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  • University of California Davis

    Sacramento, California

    Call 916-734-5959

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  • Yale University

    New Haven, Connecticut

    Call 203-200-2486

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Show all 16 locations

  • Moffitt Cancer Center

    Tampa, Florida

    Call 888-663-3488

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  • OSF Healthcare Cancer Institute

    Peoria, Illinois

    Call 309-308-3800

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  • Massachusetts General Hospital

    Boston, Massachusetts

    Call 617-724-4000

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  • Columbia University Irving Medical Center

    New York, New York

    Call 877-426-5637

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  • NYU Langone Health

    New York, New York

    Call 646-929-7870

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  • Vanderbilt University Medical Center

    Nashville, Tennessee

    Call 615-936-8422

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  • The University of Texas MD Anderson Cancer Center

    Houston, Texas

    Call 877-632-6789

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  • Sarah Cannon Research Institute at Mary Crowley

    Dallas, Texas

    Call 972-566-3000

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  • NEXT Oncology

    San Antonio, Texas

    Call 210-580-9500

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  • Huntsman Cancer Institute

    Salt Lake City, Utah

    Call 801-587-7000

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  • Fred Hutchinson Cancer Center

    Seattle, Washington

    Call 206-667-5000

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Who can participate

Inclusion criteria

  • ✓Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation
  • ✓Measurable disease by RECIST v1.1
  • ✓Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • ✓Life expectancy \>24 weeks
  • ✓Adequate organ function

Exclusion criteria

  • ✕Malignancy within the last 2 years as specified in the protocol
  • ✕Untreated brain metastases
  • ✕Other inclusion/exclusion criteria are specified in the protocol.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.