Discovery of BBO-11818, a Potent and Selective Noncovalent Inhibitor of (ON) and (OFF) KRAS with Activity against Multiple Oncogenic Mutants.
Carlos Stahlhut, Anna E Maciag, Kyle A Sullivan...
https://pubmed.ncbi.nlm.nih.gov/41790032Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06917079
Phase 1a/1b Study of BBO-11818 Evaluating Safety, Tolerability, and Efficacy in Adults With Advanced KRAS Mutant Cancers
Led by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Updated on 2026-06-02
665
Participants Needed
17
Research Sites
108 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early antitumor effects of BBO-11818, a pan-KRAS inhibitor, in adults with locally advanced unresectable or metastatic cancers that have KRAS mutations. This Phase 1, open-label, multi-center trial focuses on solid tumors including non-small cell lung cancer, pancreatic ductal adenocarcinoma, colorectal cancer, and other advanced cancers with specific KRAS mutations. The study aims to understand how BBO-11818 works alone and combined with other cancer treatments. Participants receive BBO-11818 orally, either by itself or with various intravenous treatments such as pembrolizumab, platinum chemotherapy (cisplatin or carboplatin), pemetrexed, cetuximab, mFOLFOX6, BBO-10203, mFOLFIRINOX, gemcitabine, and nab-paclitaxel. The trial includes a dose escalation phase to find the recommended dose and a dose expansion phase to further evaluate treatment combinations. Multiple treatment cohorts receive different combinations of these agents. During the study, participants will be monitored for treatment-related side effects, drug levels in the blood, and tumor response using RECIST criteria over approximately five years. Researchers will track safety events, pharmacokinetics, tumor shrinkage, duration of response, progression-free survival, and overall survival. Regular assessments include physical exams, laboratory tests, imaging scans, and evaluation of patient health and life expectancy. The study is designed to gather detailed information about BBO-11818's effects and tolerability in this patient group.
CONDITIONS
Brief Title
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed locally advanced 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 of 0 or 1
- Life expectancy greater than 24 weeks
- Adequate organ function
You will not qualify if you...
- Malignancy within the last 2 years as specified in the protocol
- Untreated brain metastases
- Other exclusion criteria as outlined in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 5 years or until disease progression or discontinuation
Participants receive BBO-11818 alone or in combination with other cancer therapies such as pembrolizumab, platinum chemotherapy, pemetrexed, cetuximab, mFOLFOX6, BBO-10203, mFOLFIRINOX, gemcitabine, and nab-paclitaxel according to their assigned cohort.
Visits occur according to treatment administration schedules and study assessments
Trial Site Locations
Total: 17 locations
1
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States, 90025
Actively Recruiting
2
University of California Davis
Sacramento, California, United States, 95817
Actively Recruiting
3
University of California San Diego Moores Cancer Center
San Diego, California, United States, 92037
Actively Recruiting
4
University of California San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
5
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
6
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
7
OSF Healthcare Cancer Institute
Peoria, Illinois, United States, 61637
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
10
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
11
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
12
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States, 75230
Actively Recruiting
13
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
14
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
15
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
16
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
17
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
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Research Team
T
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
20
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