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BBO-11818 in Adult Subjects With KRAS Mutant 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-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
Official title: A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
665
Start Date
2025-03-31
Completion Date
2029-09
Last Updated
2026-06-02
Healthy Volunteers
No
Conditions
Interventions
BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
Pembrolizumab
Patients will receive IV pembrolizumab
Platinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
Pemetrexed
Patients will receive IV pemetrexed
Cetuximab
Patients will receive IV cetuximab
mFOLFOX6
Patients may receive IV mFOLFOX6
mFOLFOX6
Patients will receive IV mFOLFOX6
BBO-10203
Participants will receive BBO-10203 orally (PO)
mFOLFIRINOX
Patients will receive IV mFOLFIRINOX
Gemcitabine
Patients will receive IV gemcitabine
Nab-paclitaxel
Patients will receive IV nab-paclitaxel
Locations (17)
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States
University of California Davis
Sacramento, California, United States
University of California San Diego Moores Cancer Center
San Diego, California, United States
University of California San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Moffitt Cancer Center
Tampa, Florida, United States
OSF Healthcare Cancer Institute
Peoria, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
NYU Langone Health
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia