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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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment350
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06343402Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung CancerPHASE1 RECRUITING 350 — — May 22, 2024Sep 1, 2031May 5, 202635 United States, Australia +3
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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 — 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 406 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel, ABP 234, Pembrolizumab, Sotorasib
AstraZeneca PLCAZN63PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel, RMC-6291, Elironrasib, Daraxonrasib
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab
Bristol-Myers Squibb CompanyBMY20PHASE3Repotrectinib, Crizotinib, Nivolumab, Carboplatin, Cisplatin
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel, PM8002, Carboplatin, Pemetrexed
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel, Zimberelimab, Domvanalimab, Pembrolizumab
GSK plc Sponsored ADRGSK4PHASE3Cobolimab, Dostarlimab, Docetaxel, Belrestotug, Pembrolizumab
Johnson & JohnsonJNJ18PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin, Osimertinib
Pfizer Inc.PFE21PHASE3Lorlatinib, Crizotinib, Avelumab, Lorlatanib, Talazoparib
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib, Drug: Furmonertinib, Furmonertinib, JAB-21822, JAB 21822
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel, TNO155, tislelizumab, DKY709
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib, AB-106
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel, Rina-S, GEN1042
Incyte CorporationINCY1PHASE3Retifanlimab, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab, Pemetrexed, Paclitaxel
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06343402Enrollment: 250 → 350
LOWMay 24, 2026NCT06343402studyFirstPostDate: changed