Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT06343402
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1a: sequential/parallel, Phase 1b: parallel'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-03-22', 'studyFirstSubmitQcDate': '2024-04-01', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'approximately 3 years', 'description': 'Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)'}, {'measure': 'Dose-limiting toxicities (DLTs)', 'timeFrame': 'approximately 3 years', 'description': 'Number of participants with dose limiting toxicities'}], 'secondaryOutcomes': [{'measure': 'To evaluate preliminary antitumor activity of BBO-8520', 'timeFrame': 'approximately 3 years', 'description': 'Objective response rate (ORR) per (RECIST v1.1)'}, {'measure': 'To evaluate preliminary antitumor activity of BBO-8520', 'timeFrame': 'approximately 3 years', 'description': 'Duration of Response (DOR) per (RECIST v1.1)'}, {'measure': 'To evaluate preliminary antitumor activity of BBO-8520', 'timeFrame': 'approximately 3 years', 'description': 'Progression-free survival (PFS) per (RECIST v1.1)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'approximately 3 years'}, {'measure': 'To characterize the pharmacokinetics (PK) of BBO-8520', 'timeFrame': 'approximately 3 years', 'description': 'Area under the curve (AUC)'}, {'measure': 'To characterize the pharmacokinetics (PK) of BBO-8520', 'timeFrame': 'approximately 3 years', 'description': 'Peak plasma drug concentration (Cmax)'}, {'measure': 'To characterize the pharmacokinetics (PK) of BBO-8520', 'timeFrame': 'approximately 3 years', 'description': 'Time to Cmax (Tmax)'}, {'measure': 'To characterize the pharmacokinetics (PK) of BBO-8520', 'timeFrame': 'approximately 3 years', 'description': 'Half life (T1/2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer', 'Metastatic Non-Small Cell Lung Cancer', 'NSCLC', 'KRAS G12C', 'Metastatic Lung Cancer', 'Advanced Lung Carcinoma']}, 'descriptionModule': {'briefSummary': '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 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.', 'detailedDescription': 'This is an open-label, multi-center, Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of BBO-8520, a direct inhibitor of KRASG12C (ON and OFF), alone and in combination with the ICI pembrolizumab in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation. The study includes dose escalation phase and dose expansion phase'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n\nExclusion Criteria:\n\n* Patients with malignancy within the last 2 years as specified in the protocol\n* Patients with untreated brain metastases\n* Patients with known hypersensitivity to BBO-8520 or its excipients\n* For Cohorts 1b and 2b:\n* Patients with a known hypersensitivity to pembrolizumab or its excipients\n* Patients with active autoimmune disease of history of autoimmune disease that might recur\n* Patients with a history of interstitial lung disease/pneumonitis that required steroids, or current interstitial lung disease/pneumonitis\n\nOther inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT06343402', 'briefTitle': 'Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TBBO8520-101'}, 'secondaryIdInfos': [{'id': 'ONKORAS-101', 'type': 'OTHER', 'domain': 'TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1a - Dose Escalation/Dose Finding Monotherapy', 'description': 'Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) as monotherapy', 'interventionNames': ['Drug: BBO-8520']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 1b - Dose Escalation/Dose Finding Combination Therapy', 'description': 'Participants enrolled in this cohort will receive BBO-8520 (different dose levels will be evaluated) once a day (QD) in combination with pembrolizumab infusion (IV)', 'interventionNames': ['Drug: BBO-8520', 'Drug: Pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2a - Dose Expansion Monotherapy', 'description': 'Participants enrolled in this cohort will receive BBO-8520 once a day (QD) as monotherapy', 'interventionNames': ['Drug: BBO-8520']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2b - Dose Expansion Combination Therapy', 'description': 'Participants enrolled in this cohort will receive BBO-8520 once a day (QD) in combination with pembrolizumab infusion (IV)', 'interventionNames': ['Drug: BBO-8520', 'Drug: Pembrolizumab']}], 'interventions': [{'name': 'BBO-8520', 'type': 'DRUG', 'description': 'Participants will receive assigned dose of BBO-8520 orally (PO), QD', 'armGroupLabels': ['Cohort 1a - Dose Escalation/Dose Finding Monotherapy', 'Cohort 1b - Dose Escalation/Dose Finding Combination Therapy', 'Cohort 2a - Dose Expansion Monotherapy', 'Cohort 2b - Dose Expansion Combination Therapy']}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Patients will receive IV pembrolizumab', 'armGroupLabels': ['Cohort 1b - Dose Escalation/Dose Finding Combination Therapy', 'Cohort 2b - Dose Expansion Combination Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California - San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'UCLA Health - Santa Monica Cancer Care', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06850', 'city': 'Norwalk', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Norwalk Hospital', 'geoPoint': {'lat': 41.1176, 'lon': -73.4079}}, {'zip': '66205', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '48282', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Henry Ford Cancer - Detroit', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Perlmutter Cancer Center - NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oncology Consultants Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NEXT Oncology', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Kinghorn Cancer Centre', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '5042', 'city': 'Bedford Park', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Flinders Medical Centre', 'geoPoint': {'lat': -35.02204, 'lon': 138.56815}}, {'zip': '5011', 'city': 'Woodville South', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'The Queen Elizabeth Hospital', 'geoPoint': {'lat': -34.88186, 'lon': 138.53477}}, {'zip': '3199', 'city': 'Frankston', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Peninsula & South Eastern Hematology and Oncology Group (PAS)', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '3051', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Juravinski Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'The Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)', 'role': 'CONTACT', 'email': 'onkoras-101ct.gov@bridgebiooncology.com', 'phone': '650-405-8440'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}