BBO-11818 treatment for adults with KRAS mutant cancer
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
Run by TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · NCT06917079 · Data updated 2026-11-12
This study is testing a new drug called BBO-11818 to see if it can help adults with certain types of cancer that have specific KRAS mutations.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 665 (estimated) |
| Sponsor | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Industry-sponsored |
| Drugs / interventions | pembrolizumab, cetuximab |
| Locations | 17 sites (Los Angeles, California and 16 other locations) |
| Status | Recruiting |
| Started | March 31, 2025 |
| Main results expected | August 2027 |
| Study ends | September 2029 |
| Registry record updated | June 2, 2026 |
| Trial ID | NCT06917079 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with histologically confirmed locally advanced or metastatic solid tumors harboring specific KRAS mutations.
✕Probably not a fit
Patients with untreated brain metastases or those with a history of malignancy within the last two years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 clinical trial evaluates the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in adults with locally advanced unresectable or metastatic solid tumors that have specific KRAS mutations. The study is open-label and multi-center, involving a dose escalation phase and a dose expansion phase, where BBO-11818 is tested alone and in combination with other therapies such as pembrolizumab and platinum chemotherapy. The trial aims to assess the drug's tolerability, pharmacokinetics, and efficacy in treating conditions like non-small cell lung cancer, pancreatic ductal adenocarcinoma, and colorectal cancer.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with KRAS mutant cancers that are difficult to treat.
How similar studies have gone: Other studies have shown promising results with KRAS inhibitors, indicating potential for success with this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 it's running
-
The Angeles Clinic and Research Institute - West Los Angeles Office
Los Angeles, California, United States Recruiting -
University of California Davis
Sacramento, California, United States Recruiting -
University of California San Diego Moores Cancer Center
San Diego, California, United States Recruiting -
University of California San Francisco Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States Recruiting -
Yale University
New Haven, Connecticut, United States Recruiting -
Moffitt Cancer Center
Tampa, Florida, United States Recruiting
Show 11 more locations
-
OSF Healthcare Cancer Institute
Peoria, Illinois, United States Recruiting -
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting -
NYU Langone Health
New York, New York, United States Recruiting -
Columbia University Irving Medical Center
New York, New York, United States Recruiting -
Vanderbilt University Medical Center
Nashville, Tennessee, United States Recruiting -
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States Recruiting -
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States Recruiting -
NEXT Oncology
San Antonio, Texas, United States Recruiting -
Huntsman Cancer Institute
Salt Lake City, Utah, United States Recruiting -
Fred Hutchinson Cancer Center
Seattle, Washington, United States Recruiting -
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia Recruiting
Study contacts
- Study coordinator: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Email: tbbo11818-101ct.gov@bbotx.com
- Phone: (650) 405-4770
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating BDTX-4933 for patients with specific cancer mutations
This study is testing a new drug called BDTX-4933 to see if it can help adults with advanced cancers that have certain gene mutations feel better and improve their treatment options.
-
Evaluating BBO-8520 for treating KRAS G12C non-small cell lung cancer
This study is testing a new drug called BBO-8520 to see if it can safely help adults with a specific type of lung cancer that has a KRAS G12C mutation, both on its own and when combined with another treatment.
-
Combining Adagrasib with Stereotactic Radiosurgery for Brain Metastases in Lung Cancer
This study is testing whether combining a targeted therapy called adagrasib with a type of focused radiation treatment can help people with lung cancer that has spread to the brain feel better.
-
Evaluating FMC-376 for advanced solid tumors with KRAS G12C mutations
This study is testing a new drug called FMC-376 to see if it can help people with advanced solid tumors that have a specific KRAS G12C mutation.
-
T cell therapy targeting KRAS G12D in advanced solid tumors
This trial will test whether autologous T cells engineered to recognize KRAS G12D can help adults with unresectable or metastatic solid tumors who have the matching HLA type.
-
Evaluating a new CAR T-cell therapy for solid tumors expressing MSLN
This study is testing a new CAR T-cell therapy to see if it can safely treat adults with solid tumors like colorectal and lung cancer that express a specific protein.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.