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BBO-11818

Phase 1

Non-Small Cell Lung Cancer | Small molecule | Oncology |BridgeBio Oncology Therapeutics, Inc.|Last Updated: Jun 2, 2026

Target and mechanism

Molecular targetKRAS
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment665

FDA Designations

No designations recorded

Clinical trial landscape

BBO-11818 · 1 trial · 14 indications

Phase 1 1
NCT06917079BBO-11818 in Adult Subjects With KRAS Mutant CancerNon-Small Cell Lung Cancer
RECRUITING665 Analytics
PHASE1RECRUITING
BBO-11818 in Adult Subjects With KRAS Mutant Cancer
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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, cetuximab ± mFOLFOX6, BBO-10203 + mFOLFOX6, BBO-10203 + cetuximab, cetuximab, mFOLFIRINOX, gemcitabine + nab-paclitaxel, or BBO-10203
approximately 5 years

Secondary Endpoints

Objective response rate (ORR) per RECIST v1.1 and CNS RECIST
approximately 5 years
Clinical benefit rate (CBR) per RECIST v1.1
approximately 5 years
Duration of Response (DOR) per RECIST v1.1
approximately 5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1a - Dose Escalation MonotherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 as monotherapy
Cohort 1b - Dose Escalation Combination Therapy (Pembrolizumab)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
Cohort 1c - Dose Escalation Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)
Cohort 1d - Dose Escalation Combination Therapy (Cetuximab ± mFOLFOX6)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV)
Cohort 1e - Dose Escalation Combination Therapy (BBO-10203 + mFOLFOX6)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV)
Cohort 1f - Dose Escalation Combination Therapy (BBO-10203 + Cetuximab)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV)
Cohort 1g - Dose Escalation Combination Therapy (Cetuximab)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)
Cohort 1h - Dose Escalation Combination Therapy (mFOLFIRINOX)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV)
Cohort 1i - Dose Escalation Combination Therapy (Gemcitabine + Nab-paclitaxel)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV)
Cohort 1j - Dose Escalation Combination Therapy (BBO-10203)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203
Cohort 2a - Dose Expansion MonotherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 as monotherapy
Cohort 2b - Dose Expansion Combination (Pembrolizumab)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV)
Cohort 2c - Dose Expansion Combination Therapy (Pembrolizumab + Cis/carboplatin + Pemetrexed)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with pembrolizumab infusion (IV), cis/carboplatin infusion (IV), and pemetrexed infusion (IV)
Cohort 2d - Dose Expansion Combination Therapy (Cetuximab ± mFOLFOX6)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV) with or without mFOLFOX6 infusion (IV)
Cohort 2e - Dose Expansion Combination Therapy (BBO-10203 + mFOLFOX6)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and mFOLFOX6 infusion (IV)
Cohort 2f - Dose Expansion Combination Therapy (BBO-10203 + Cetuximab)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203 and cetuximab infusion (IV)
Cohort 2g - Dose Expansion Combination Therapy (Cetuximab)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with cetuximab infusion (IV)
Cohort 2h - Dose Expansion Combination Therapy (mFOLFIRINOX)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with mFOLFIRINOX infusion (IV)
Cohort 2i - Dose Expansion Combination Therapy (Gemcitabine + Nab-paclitaxel)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with gemcitabine infusion (IV) and nab-paclitaxel infusion (IV)
Cohort 2j - Dose Expansion Combination Therapy (BBO-10203)EXPERIMENTALParticipants enrolled in this cohort will receive BBO-11818 in combination with BBO-10203

Interventions

NameTypeDescription
BBO-11818DRUGParticipants will receive assigned dose of BBO-11818 orally (PO)
PembrolizumabDRUGPatients will receive IV pembrolizumab
Platinum chemotherapy (cisplatin or carboplatin)DRUGPatients will receive IV platinum chemotherapy (cisplatin or carboplatin)
PemetrexedDRUGPatients will receive IV pemetrexed
CetuximabDRUGPatients will receive IV cetuximab
mFOLFOX6DRUGPatients may receive IV mFOLFOX6
BBO-10203DRUGParticipants will receive BBO-10203 orally (PO)
mFOLFIRINOXDRUGPatients will receive IV mFOLFIRINOX
GemcitabineDRUGPatients will receive IV gemcitabine
Nab-paclitaxelDRUGPatients will receive IV nab-paclitaxel
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

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 * Lif...

Countries:United StatesAustralia
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Competitive Landscape -Non-Small Cell Lung Cancer 391 trials

Recent Changes (Last 90 Days)

MEDIUMJun 2, 2026NCT06917079Enrollment: 387 → 665
MEDIUMJun 2, 2026NCT06917079Enrollment: 387 → 665
MEDIUMJun 2, 2026NCT06917079Enrollment: 387 → 665

Frequently asked questions about BBO-11818

What is BBO-11818 used for?

BBO-11818 is an investigational small molecule being developed for non-small cell lung cancer (NSCLC). It is also being studied in other KRAS-mutant cancers, including pancreatic ductal adenocarcinoma, colorectal cancer, and solid tumors. The drug is currently in Phase 1 clinical development.

What does BBO-11818 target?

BBO-11818 targets KRAS, a protein involved in cell growth and division. Mutations in KRAS, such as G12A, G12C, G12D, G12S, and G12V, are associated with various cancers. By targeting KRAS, BBO-11818 aims to interfere with cancer cell signaling pathways.

Who is developing BBO-11818?

BBO-11818 is being developed by BridgeBio Oncology Therapeutics, Inc. (ticker: BBOT). The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with KRAS-mutant cancers.

What phase is BBO-11818 in?

BBO-11818 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary activity.

What clinical trials is BBO-11818 in?

BBO-11818 is being evaluated in a Phase 1 clinical trial with the identifier NCT06917079. The trial is titled 'BBO-11818 in Adult Subjects With KRAS Mutant Cancer' and is currently recruiting participants in the United States and Australia.

Is BBO-11818 the same as other KRAS inhibitors?

BBO-11818 is a distinct investigational drug targeting KRAS. It is being studied in cancers with specific KRAS mutations, including G12A, G12C, G12D, G12S, and G12V. Its development is separate from other KRAS-targeting therapies.