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

Recruiting now · Phase 1

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

In brief

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.

Key facts

Study ID

NCT06343402

Run by

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

People needed

350

Starts

2024-05-22

Expected to finish

2031-09-01

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• O'Neal Comprehensive Cancer Center at UAB — Birmingham, Alabama, United States (enrolling)
• University of California - San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• UCLA Health - Santa Monica Cancer Care — Santa Monica, California, United States (enrolling)
• University of Colorado Cancer Center — Aurora, Colorado, United States (enrolling)
• Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Norwalk Hospital — Norwalk, Connecticut, United States (enrolling)
• OSF Saint Francis Medical Center — Peoria, Illinois, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Henry Ford Cancer - Detroit — Detroit, Michigan, United States (enrolling)
• Roswell Park Cancer Institute — Buffalo, New York, United States (enrolling)
• Perlmutter Cancer Center - NYU Langone Health — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• USOR - Oncology Associates of Oregon, P.C — Eugene, Oregon, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Oncology Consultants Texas Medical Center — Houston, Texas, United States (enrolling)
• USOR - Texas Oncology - (DFW) Waco — Waco, Texas, United States (enrolling)
• Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• NEXT Oncology — Fairfax, Virginia, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Northwest Medical Specialties — Tacoma, Washington, United States (enrolling)
• Kinghorn Cancer Centre — Darlinghurst, New South Wales, Australia (enrolling)
• Flinders Medical Centre — Bedford Park, South Australia, Australia (enrolling)
• The Queen Elizabeth Hospital — Woodville South, South Australia, Australia (enrolling)

Full record on ClinicalTrials.gov

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