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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)
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 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.
Official title: A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2024-05-22
Completion Date
2031-09
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
BBO-8520
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Pembrolizumab
Patients will receive IV pembrolizumab
BBO-10203
Participants will receive assigned dose of BBO-8520 orally (PO), QD
Locations (31)
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
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
Juravinski Cancer Centre
Hamilton, Ontario, Canada
The Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada