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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) • ClinicalTrials.gov ID: NCT06343402

Registry updated: 2026-09-03
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Description

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.

Interventions

  • BBO-8520 (Drug)
    Participants will receive assigned dose of BBO-8520 orally (PO), QD
  • Pembrolizumab (Drug)
    Patients will receive IV pembrolizumab
  • BBO-10203 (Drug)
    Participants will receive assigned dose of BBO-8520 orally (PO), QD

Eligibility criteria

Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Exclusion Criteria: * Patients with malignancy within the last 2 years as specified in the protocol * Patients with untreated or unstable 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 might recur * Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis Other inclusion/exclusion criteria may apply

Conditions

Non-small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer NSCLC KRAS G12C Metastatic Lung Cancer Advanced Lung Carcinoma

Locations

  • 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
  • University of Maryland Marlene & Stewart Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, 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
  • Cross Cancer Institute — Edmonton, Alberta, Canada
  • Juravinski Cancer Centre — Hamilton, Ontario, Canada
  • The Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • Jewish General Hospital — Montreal, Quebec, Canada
  • Rigshospitalet — Copenhagen, Denmark
  • Vall d'Hebron University Hospital — Horta-Guinardó, Barcelona, Spain
  • START Barcelona - Hospital HM Nou Delfos — Barcelona, Spain
  • START Madrid - Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
  • Hospital Universitario Quirónsalud Madrid — Madrid, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record