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

NCT06343402

RecruitingPhase 1

Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

Conditions: Non-small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer, NSCLC, KRAS G12C, Metastatic Lung Cancer

Interventions: BBO-8520, Pembrolizumab, BBO-10203

Countries: United States, Australia, Canada, Denmark, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (38)
  • Birmingham, Alabama, United States
  • La Jolla, California, United States
  • San Francisco, California, United States
  • Santa Monica, California, United States
  • Aurora, Colorado, United States
  • New Haven, Connecticut, United States
  • Norwalk, Connecticut, United States
  • Peoria, Illinois, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Detroit, Michigan, United States
  • Buffalo, New York, United States
  • New York, New York, United States
  • New York, New York, United States
  • Cleveland, Ohio, United States
  • Eugene, Oregon, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Waco, Texas, United States
  • Salt Lake City, Utah, United States
  • Fairfax, Virginia, United States
  • Seattle, Washington, United States
  • Tacoma, Washington, United States
  • Darlinghurst, New South Wales, Australia
  • Bedford Park, South Australia, Australia
  • Woodville South, South Australia, Australia
  • Frankston, Victoria, Australia
  • Melbourne, Victoria, Australia
  • Nedlands, Western Australia, Australia
  • Edmonton, Alberta, Canada
  • + 8 more on CT.gov