BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Recruiting · NCT06917079 · Interventional (participants receive a specific treatment) · Lead sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
View the official record on ClinicalTrials.gov →Interventions studied
BBO-10203BBO-11818CetuximabGemcitabineNab-paclitaxelPembrolizumabPemetrexedPlatinum chemotherapy (cisplatin or carboplatin)mFOLFIRINOXmFOLFOX6
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor with KRAS G12A, G12C, G12D, G12S, or G12V mutation
- Measurable disease by RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Life expectancy \>24 weeks
- Adequate organ function
Exclusion criteria
- Malignancy within the last 2 years as specified in the protocol
- Untreated brain metastases
- ther inclusion/exclusion criteria are specified in the protocol.
Where it is running
17 locations listed across 10 US states.
- 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