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BBO-11818 in Adult Subjects With KRAS Mutant Cancer
NCT06917079 · TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
In plain English
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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
About this study
This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-11818, a pan-KRAS inhibitor, alone and in combination with pembrolizumab, pembrolizumab +/- cis/carboplatin + pemetrexed, cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors. The study includes dose escalation phase and dose expansion phase.
Eligibility 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.
Study design
Enrollment target: 387 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-31
Estimated completion: 2029-09
Last updated: 2026-03-23
Interventions
Drug: BBO-11818Drug: PembrolizumabDrug: Platinum chemotherapy (cisplatin or carboplatin)Drug: PemetrexedDrug: CetuximabDrug: FOLFOXDrug: NALIRIFOXDrug: GemcitabineDrug: Nab-paclitaxel
Primary outcomes
- • Incidence and severity of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) (approximately 5 years)
- • Determine recommended dose of BBO-11818 in combination with pembrolizumab +/- cis/carboplatin + pemetrexed, or cetuximab +/- FOLFOX, NALIRIFOX, or Gemcitabine + Nab-paclitaxel (approximately 5 years)
Sponsor
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · industry
Contacts & investigators
ContactTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · contact · tbbo11818-101ct.gov@bbotx.com
All locations (11)
The Angeles Clinic and Research Institute - West Los Angeles OfficeRecruiting
Los Angeles, California, United States
University of California San Diego Moores Cancer CenterRecruiting
San Diego, California, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
NYU Langone HealthRecruiting
New York, New York, United States
Columbia University Irving Medical CenterRecruiting
New York, New York, United States
Sarah Cannon Research Institute at Mary CrowleyRecruiting
Dallas, Texas, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Fred Hutchinson Cancer CenterRecruiting
Seattle, Washington, United States