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BBO-8520

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |BridgeBio Oncology Therapeutics, Inc.|Last Updated: May 5, 2026

Target and mechanism

Molecular targetKRAS
Target classGene
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment350

FDA Designations

No designations recorded

Clinical trial landscape

BBO-8520 · 1 trial · 6 indications

Phase 1 1
NCT06343402Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung CancerNon-small Cell Lung Cancer
RECRUITING350 Analytics
PHASE1RECRUITING
Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events
approximately 3 years

Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

Dose-limiting toxicities (DLTs)
approximately 3 years

Number of participants with dose limiting toxicities

Secondary Endpoints

To evaluate preliminary antitumor activity of BBO-8520
approximately 3 years
Overall Survival (OS)
approximately 3 years
To characterize the pharmacokinetics (PK) of BBO-8520
approximately 3 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1a - Dose Escalation/Dose Finding MonotherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy
Cohort 1b - Dose Escalation/Dose Finding Combination TherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV)
Cohort 2a - Dose Expansion MonotherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy
Cohort 2b - Dose Expansion Combination TherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)
Cohort 1b Safety Lead-In - Dose Expansion Doublet Combination TherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
Cohort 1b - Dose Expansion Doublet Combination TherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD)
Cohort 1b Safety Lead-In - Dose Expansion Triplet Combination TherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV)
Cohort 1b - Dose Expansion Triplet Combination TherapyEXPERIMENTALParticipants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with BBO-10203 once a day (QD) and pembrolizumab infusion (IV)

Interventions

NameTypeDescription
BBO-8520DRUGParticipants will receive assigned dose of BBO-8520 orally (PO), QD
PembrolizumabDRUGPatients will receive IV pembrolizumab
BBO-10203DRUGParticipants will receive assigned dose of BBO-8520 orally (PO), QD
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation * Measurable disease by RECIST v1.1 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 Exclusion Criteria: * Patients with mali...

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

Frequently asked questions about BBO-8520

What is BBO-8520 used for?

BBO-8520 is an investigational small molecule being developed for the treatment of non-small cell lung cancer (NSCLC), including metastatic non-small cell lung cancer and advanced lung carcinoma. It is currently in Phase 1 clinical development for these indications.

What does BBO-8520 target?

BBO-8520 targets KRAS, specifically the KRAS G12C mutation, which is a gene involved in cell growth and division. By targeting this mutated gene, BBO-8520 is designed to interfere with cancer cell proliferation in non-small cell lung cancer.

Who is developing BBO-8520?

BBO-8520 is being developed by BridgeBio Oncology Therapeutics, Inc., a company listed under the ticker symbol BBOT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with KRAS G12C-mutated non-small cell lung cancer.

What phase is BBO-8520 in?

BBO-8520 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy.

What clinical trials is BBO-8520 in?

BBO-8520 is being studied in a Phase 1 open-label trial with the identifier NCT06343402. This trial is recruiting adult subjects with KRAS G12C non-small cell lung cancer and aims to enroll approximately 350 participants across the United States, Australia, Canada, Denmark, and Spain.

Is BBO-8520 the same as any other drug?

BBO-8520 is a distinct investigational compound developed by BridgeBio Oncology Therapeutics. It is not known to be the same as any other marketed drug. Its unique mechanism targets the KRAS G12C mutation, which is a specific genetic alteration found in some non-small cell lung cancers.