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BBO-11818 in Adult Subjects With KRAS Mutant Cancer
RecruitingPhase 1
A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-11818 in Subjects With Advanced KRAS Mutant Cancers
Who can join
Ages 18 and older · All sexes
Full 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 * 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.
About the study
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.
What is being tested
- BBO-11818 (drug)
- Pembrolizumab (drug)
- Platinum chemotherapy (cisplatin or carboplatin) (drug)
- Pemetrexed (drug)
- Cetuximab (drug)
- mFOLFOX6 (drug)
Sponsor: TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Participants: 665 · Started: Mar 31, 2025
Contact the study team
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Phone: (650) 405-4770
Official record on ClinicalTrials.gov — NCT06917079
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.