BBO-11818 treatment for adults with KRAS mutant cancer
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers
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 |
| Enrollment | 387 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Industry-sponsored |
| Drugs / interventions | pembrolizumab, cetuximab |
| Locations | 11 sites (Los Angeles, California and 10 other locations) |
| Trial ID | NCT06917079 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed locally advanced or metastatic solid tumors harboring specific KRAS mutations.
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.
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 performed: Other studies have shown promising results with KRAS inhibitors, indicating potential for success with this novel approach.
Eligibility criteria
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 Exclusion Criteria: * Malignancy within the last 2 years as specified in the protocol * Untreated brain metastases * Known hypersensitivity to BBO-11818 or its excipients Other inclusion/exclusion criteria are specified in the protocol.
Where this trial is running
Los Angeles, California and 10 other locations
- The Angeles Clinic and Research Institute - West Los Angeles Office — Los Angeles, California, United States (Recruiting)
- University of California San Diego Moores Cancer Center — San Diego, California, United States (Recruiting)
- Moffitt Cancer Center — Tampa, Florida, 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)
- 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)
Study contacts
- Study coordinator: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
- Email: tbbo11818-101ct.gov@bbotx.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.