Clinical trial Recruiting at 17 sites Phase 1 Interventional Ages 18 and up

BBO-11818 treatment for adults with KRAS mutant cancer

Official title: A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers

Run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · NCT06917079 · Data updated 2026-11-12

This study is testing a new drug called BBO-11818 to see if it can help adults with certain types of cancer that have specific KRAS mutations.

More Non-Small Cell Lung Cancer trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment665 (estimated)
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Industry-sponsored
Drugs / interventionspembrolizumab, cetuximab
Locations17 sites (Los Angeles, California and 16 other locations)
StatusRecruiting
StartedMarch 31, 2025
Main results expectedAugust 2027
Study endsSeptember 2029
Registry record updatedJune 2, 2026
Trial IDNCT06917079 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with histologically confirmed locally advanced or metastatic solid tumors harboring specific KRAS mutations.

Probably not a fit

Patients with untreated brain metastases or those with a history of malignancy within the last two years may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial evaluates the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in adults with locally advanced unresectable or metastatic solid tumors that have specific KRAS mutations. The study is open-label and multi-center, involving a dose escalation phase and a dose expansion phase, where BBO-11818 is tested alone and in combination with other therapies such as pembrolizumab and platinum chemotherapy. The trial aims to assess the drug's tolerability, pharmacokinetics, and efficacy in treating conditions like non-small cell lung cancer, pancreatic ductal adenocarcinoma, and colorectal cancer.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with KRAS mutant cancers that are difficult to treat.

How similar studies have gone: Other studies have shown promising results with KRAS inhibitors, indicating potential for success with this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The Angeles Clinic and Research Institute - West Los Angeles Office
    Los Angeles, California, United States
    Recruiting
  • University of California Davis
    Sacramento, California, United States
    Recruiting
  • University of California San Diego Moores Cancer Center
    San Diego, California, United States
    Recruiting
  • University of California San Francisco Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, United States
    Recruiting
  • Yale University
    New Haven, Connecticut, United States
    Recruiting
  • Moffitt Cancer Center
    Tampa, Florida, United States
    Recruiting
Show 11 more locations
  • OSF Healthcare Cancer Institute
    Peoria, Illinois, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • NYU Langone Health
    New York, New York, United States
    Recruiting
  • Columbia University Irving Medical Center
    New York, New York, United States
    Recruiting
  • Vanderbilt University Medical Center
    Nashville, Tennessee, United States
    Recruiting
  • Sarah Cannon Research Institute at Mary Crowley
    Dallas, Texas, United States
    Recruiting
  • The University of Texas MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting
  • NEXT Oncology
    San Antonio, Texas, United States
    Recruiting
  • Huntsman Cancer Institute
    Salt Lake City, Utah, United States
    Recruiting
  • Fred Hutchinson Cancer Center
    Seattle, Washington, United States
    Recruiting
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria, Australia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Evaluating BDTX-4933 for patients with specific cancer mutations

    This study is testing a new drug called BDTX-4933 to see if it can help adults with advanced cancers that have certain gene mutations feel better and improve their treatment options.

    Recruiting at 34 sites Phase 1/2 Servier · Gilbert, Arizona and 48 other locations · NCT05786924

  • Evaluating BBO-8520 for treating KRAS G12C non-small cell lung cancer

    This study is testing a new drug called BBO-8520 to see if it can safely help adults with a specific type of lung cancer that has a KRAS G12C mutation, both on its own and when combined with another treatment.

    Recruiting at 38 sites Phase 1 TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Birmingham, Alabama and 37 other locations · NCT06343402

  • Combining Adagrasib with Stereotactic Radiosurgery for Brain Metastases in Lung Cancer

    This study is testing whether combining a targeted therapy called adagrasib with a type of focused radiation treatment can help people with lung cancer that has spread to the brain feel better.

    Recruiting at 3 sites Phase 2 Hoosier Cancer Research Network · Columbus, Ohio and 2 other locations · NCT06248606

  • Evaluating FMC-376 for advanced solid tumors with KRAS G12C mutations

    This study is testing a new drug called FMC-376 to see if it can help people with advanced solid tumors that have a specific KRAS G12C mutation.

    Recruiting at 20 sites Phase 1/2 Frontier Medicines Corporation · La Jolla, California and 25 other locations · NCT06244771

  • T cell therapy targeting KRAS G12D in advanced solid tumors

    This trial will test whether autologous T cells engineered to recognize KRAS G12D can help adults with unresectable or metastatic solid tumors who have the matching HLA type.

    Recruiting at 18 sites Phase 1 AstraZeneca · Duarte, California and 17 other locations · NCT06218914

  • Evaluating a new CAR T-cell therapy for solid tumors expressing MSLN

    This study is testing a new CAR T-cell therapy to see if it can safely treat adults with solid tumors like colorectal and lung cancer that express a specific protein.

    Recruiting at 12 sites Phase 1/2 A2 Biotherapeutics Inc. · Gilbert, Arizona and 11 other locations · NCT06051695

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.