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

Last updated: January 14, 2025
Sponsor: TheRas, Inc., d/b/a BridgeBio Oncology Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Colorectal Cancer

Carcinoma

Cancer

Treatment

Pembrolizumab

BBO-8520

Clinical Study ID

NCT06343402
TBBO8520-101
ONKORAS-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically documented locally advanced and unresectable or metastatic non-smallcell lung cancer with a KRAS G12C mutation

  • Measurable disease by RECIST v1.1

  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Exclusion

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 mightrecur

  • Patients with a history of interstitial lung disease/pneumonitis that requiredsteroids, or current interstitial lung disease/pneumonitis

Other inclusion/exclusion criteria may apply

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Pembrolizumab
Phase: 1
Study Start date:
May 22, 2024
Estimated Completion Date:
February 29, 2028

Study 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

Connect with a study center

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales 2010
    Australia

    Active - Recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • The Queen Elizabeth Hospital

    Woodville South, South Australia 5011
    Australia

    Active - Recruiting

  • Peninsula & South Eastern Hematology and Oncology Group (PAS)

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3051
    Australia

    Active - Recruiting

  • University of California - San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Active - Recruiting

  • UCLA Health - Santa Monica Cancer Care

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Yale Cancer Center

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Norwalk Hospital

    Norwalk, Connecticut 06850
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66205
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Huntsman Cancer Institute

    Salt Lake City, Utah 84112
    United States

    Active - Recruiting

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

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