> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/open-label-study-of-bbo-8520-in-adult-subjects-with-krasg12c-4aa5e874-cb9d-481a-b59f-4544801890ff > Record changed: 2026-10-13 # Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer NCT06343402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) Participants 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) Lead sponsor TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) Start date 2024-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) Number of sites 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Title and summary **Summary** A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Short title** Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Official title** A Phase 1a/1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Dates **Completion date** 2031-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **First posted** 2024-04-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Registry last updated** 2026-05-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Primary completion date** 2031-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Start date** 2024-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Size and sites **Participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Planned participants** 350 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Number of sites** 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Lead sponsor** TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Identifiers **Registry ID** NCT06343402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **ClinicalTrials.gov ID** NCT06343402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Outcomes ### Primary outcomes 1. Adverse Events Timeframe: approximately 3 years Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) 2. Dose-limiting toxicities (DLTs) Timeframe: approximately 3 years Number of participants with dose limiting toxicities ### Secondary outcomes 1. To evaluate preliminary antitumor activity of BBO-8520 Timeframe: approximately 3 years Objective response rate (ORR) per (RECIST v1.1) 2. To evaluate preliminary antitumor activity of BBO-8520 Timeframe: approximately 3 years Duration of Response (DOR) per (RECIST v1.1) 3. To evaluate preliminary antitumor activity of BBO-8520 Timeframe: approximately 3 years Progression-free survival (PFS) per (RECIST v1.1) 4. Overall Survival (OS) Timeframe: approximately 3 years 5. To characterize the pharmacokinetics (PK) of BBO-8520 Timeframe: approximately 3 years Area under the curve (AUC) 6. To characterize the pharmacokinetics (PK) of BBO-8520 Timeframe: approximately 3 years Peak plasma drug concentration (Cmax) 7. To characterize the pharmacokinetics (PK) of BBO-8520 Timeframe: approximately 3 years Time to Cmax (Tmax) 8. To characterize the pharmacokinetics (PK) of BBO-8520 Timeframe: approximately 3 years Half life (T1/2) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 malignancy within the last 2 years as specified in the protocol - Patients with untreated or unstable brain metastases - Patients with known hypersensitivity to BBO-8520 or its excipients - For Cohorts 1b and 2b: - Patients with a known hypersensitivity to pembrolizumab or its excipients - Patients with active autoimmune disease of history of autoimmune disease that might recur - Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis Other inclusion/exclusion criteria may apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Sites - O'Neal Comprehensive Cancer Center at UABBirmingham, United StatesRecruiting - University of California - San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - University of California San FranciscoSan Francisco, United StatesRecruiting - UCLA Health - Santa Monica Cancer CareSanta Monica, United StatesRecruiting - University of Colorado Cancer CenterAurora, United StatesRecruiting - Yale Cancer CenterNew Haven, United StatesRecruiting - Norwalk HospitalNorwalk, United StatesRecruiting - OSF Saint Francis Medical CenterPeoria, United StatesRecruiting - University of Kansas Medical CenterKansas City, United StatesRecruiting - Henry Ford Cancer - DetroitDetroit, United StatesRecruiting - Roswell Park Cancer InstituteBuffalo, United StatesRecruiting - Perlmutter Cancer Center - NYU Langone HealthNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - USOR - Oncology Associates of Oregon, P.CEugene, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting - Oncology Consultants Texas Medical CenterHouston, United StatesRecruiting - USOR - Texas Oncology - (DFW) WacoWaco, United StatesRecruiting - Huntsman Cancer InstituteSalt Lake City, United StatesRecruiting - NEXT OncologyFairfax, United StatesRecruiting - Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting - Northwest Medical SpecialtiesTacoma, United StatesRecruiting - Kinghorn Cancer CentreDarlinghurst, AustraliaRecruiting - Flinders Medical CentreBedford Park, AustraliaRecruiting - The Queen Elizabeth HospitalWoodville South, AustraliaRecruiting And 10 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## References ### Other registry identifiers - ONKORAS-101 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06343402) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)](https://trialight.com/data/company/theras-inc-d-b-a-bbot-bridgebio-oncology-therapeutics-3f7980ba-3072-490d-a9b0-02f82f13beb4.md) ### Conditions (4) - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) - [Lung carcinoma](https://trialight.com/data/condition/lung-carcinoma-8cf46a3c-0bd0-5247-adda-142fcb8391aa.md) - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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