BBO-11818 in Adult Subjects 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
TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
387 participants
Mar 31, 2025
INTERVENTIONAL
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria3
- Malignancy within the last 2 years as specified in the protocol
- Untreated brain metastases
- Known hypersensitivity to BBO-11818 or its excipients
Interventions
Participants will receive assigned dose of BBO-11818 orally (PO)
Patients will receive IV pembrolizumab
Patients will receive IV platinum chemotherapy (cisplatin or carboplatin)
Patients will receive IV pemetrexed
Patients will receive IV cetuximab
Patients will receive IV FOLFOX
Patients will receive IV NALIRIFOX
Patients will receive IV Gemcitabine
Patients will receive IV Nab-Paclitaxel
Locations(10)
View Full Details on ClinicalTrials.gov
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NCT06917079