NCT06917079 · TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
What this study 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.
View original scientific description
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.
Interventions
DRUG
BBO-11818
Participants will receive assigned dose of BBO-11818 orally (PO)
DRUG
Pembrolizumab
Patients will receive IV pembrolizumab
DRUG
Platinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
DRUG
Pemetrexed
Patients will receive IV pemetrexed
DRUG
Cetuximab
Patients will receive IV cetuximab
DRUG
mFOLFOX6
Patients may receive IV mFOLFOX6
DRUG
mFOLFOX6
Patients will receive IV mFOLFOX6
DRUG
BBO-10203
Participants will receive BBO-10203 orally (PO)
DRUG
mFOLFIRINOX
Patients will receive IV mFOLFIRINOX
DRUG
Gemcitabine
Patients will receive IV gemcitabine
DRUG
Nab-paclitaxel
Patients will receive IV nab-paclitaxel
Primary outcome measures
Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Time frame: approximately 5 years
Determine recommended dose of BBO-11818 in combination with pembrolizumab ± cis/carboplatin + pemetrexed, cetuximab ± mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 + cetuximab, cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203
Time frame: approximately 5 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 Other inclusion/exclusion criteria are specified in the protocol.
Where
- Los Angeles, California
- Sacramento, California
- San Diego, California
- San Francisco, California
- New Haven, Connecticut
- Tampa, Florida
- Peoria, Illinois
- Boston, Massachusetts
- New York, New York
- Nashville, Tennessee
- Dallas, Texas
- Houston, Texas
And 3 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations