BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Start Date
3/31/2025
Completion Date
9/1/2029
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.
Detailed Description
This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab + cis/carboplatin + pemetrexed, cetuximab, cetuximab + mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 +cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203 in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes a dose escalation phase and a dose expansion phase.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
BBO-11818
Pembrolizumab
Platinum chemotherapy (cisplatin or carboplatin)
Pemetrexed
Cetuximab
mFOLFOX6
mFOLFOX6
BBO-10203
mFOLFIRINOX
Gemcitabine
Nab-paclitaxel
Conditions
Locations
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California 90025
United States
University of California Davis
Sacramento, California 95817
United States
University of California San Diego Moores Cancer Center
San Diego, California 92037
United States
University of California San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94158
United States
Yale University
New Haven, Connecticut 06510
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
OSF Healthcare Cancer Institute
Peoria, Illinois 61637
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
NYU Langone Health
New York, New York 10016
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas 75230
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
NEXT Oncology
San Antonio, Texas 78229
United States
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia