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Research Report
BBO-11818: An Investigational PanKRAS Dual Inhibitor for Advanced Solid Tumors
I. Introduction to BBO-11818
A. Overview of BBO-11818 as an Investigational Agent
BBO-11818 is an orally bioavailable, small molecule therapeutic currently under investigation for the treatment of advanced solid tumors characterized by KRAS mutations.[1] Its development represents a focused effort to target KRAS, an oncogene that has historically presented significant challenges to drug developers, often being described as "undruggable".[2] The progression of BBO-11818 into clinical trials signifies a potential advancement in providing new therapeutic options for patients with these difficult-to-treat malignancies.
B. The Unmet Medical Need in KRAS-Mutant Cancers
Mutations in the KRAS gene are among the most frequently observed oncogenic drivers in human cancers. They are particularly prevalent in some of the deadliest malignancies, occurring in approximately 30% of non-small cell lung cancer (NSCLC) cases, 40% of colorectal cancer (CRC) cases, and an overwhelming 90% of pancreatic ductal adenocarcinomas (PDAC).[2] While the advent of first-generation KRASG12C-specific inhibitors marked a breakthrough, a substantial unmet medical need persists. This need encompasses therapies for tumors driven by other KRAS variants (such as G12D and G12V) and strategies to overcome or delay the onset of adaptive resistance, which can limit the efficacy of existing targeted agents.[1] For many patients with KRAS-mutant cancers, current standard-of-care treatments offer limited efficacy, underscoring the urgency for novel therapeutic approaches.[1]
C. Developer: BridgeBio Oncology Therapeutics (BBOT) and Key Collaborations
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/04/08 | Phase 1 | Recruiting | TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) |
FDA Drug Approvals
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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No HSA approvals found for this drug. |
NMPA Drug Approvals
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No NMPA approvals found for this drug. |
PPB Drug Approvals
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No PPB approvals found for this drug. |
TGA Drug Approvals
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No TGA approvals found for this drug. |
Health Canada Drug Approvals
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No Health Canada approvals found for this drug. |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
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No UK EMC drug information found for this drug. |
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