BBO-11818 in Adult Subjects With KRAS Mutant Cancer

Last updated: March 20, 2026
Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Overall Status: Active - Recruiting

Phase

1

Condition

Non-small Cell Lung Cancer

Adenocarcinoma

Neoplasm Metastasis

Treatment

FOLFOX

Platinum chemotherapy (cisplatin or carboplatin)

Nab-paclitaxel

Clinical Study ID

NCT06917079
TBBO11818-101
KONQUER-101
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion

Exclusion Criteria:

  • Malignancy within the last 2 years as specified in the protocol

  • Untreated brain metastases

  • Known hypersensitivity to BBO-11818 or its excipients

Other inclusion/exclusion criteria are specified in the protocol.

Study Design

Total Participants: 387
Treatment Group(s): 9
Primary Treatment: FOLFOX
Phase: 1
Study Start date:
March 31, 2025
Estimated Completion Date:
September 30, 2029

Study Description

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 +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes dose escalation phase and dose expansion phase.

Connect with a study center

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

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • University of California San Diego Moores Cancer Center

    San Diego, California 92037
    United States

    Active - Recruiting

  • University of California San Diego Moores Cancer Center

    San Diego 5391811, California 5332921 92037
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Columbia University Irving Medical Center

    New York, New York 10032
    United States

    Active - Recruiting

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Active - Recruiting

  • NYU Langone Health

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Sarah Cannon Research Institute at Mary Crowley

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Sarah Cannon Research Institute at Mary Crowley

    Dallas 4684888, Texas 4736286 75230
    United States

    Site Not Available

  • The University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City 5780993, Utah 5549030 84112
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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