Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-25 @ 11:07 PM
Study NCT ID:
NCT04460456
Status:
UNKNOWN
Last Update Posted:
2022-06-30
First Post:
2020-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2022-07-18', 'unreleaseDate': '2022-07-22'}, {'resetDate': '2023-06-09', 'releaseDate': '2022-07-22'}], 'estimatedResultsFirstSubmitDate': '2022-07-18'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582435', 'term': 'pembrolizumab'}, {'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-06', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of subjects experiencing dose limiting toxicities', 'timeFrame': '28 days', 'description': 'Part 1 and 3 only'}, {'measure': 'The incidence and severity of adverse events (AEs) and serious adverse events', 'timeFrame': '2 years', 'description': 'Parts 1, 2, 3, 4, and 5'}, {'measure': 'Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)', 'timeFrame': '2 years', 'description': 'Parts 2, 4, and 5'}, {'measure': 'Duration of response, defined as the time from date of first response (CR or PR)', 'timeFrame': '2 years', 'description': 'Parts 2, 4, and 5'}], 'secondaryOutcomes': [{'measure': 'Objective response rate, defined as confirmed Complete Response (CR) or Partial Response (PR)', 'timeFrame': '2 years', 'description': 'Parts1 and 3 only'}, {'measure': 'Duration of response, defined as the time from date of first response (CR or PR)', 'timeFrame': '2 years', 'description': 'Parts 1 and 3 only'}, {'measure': 'Disease control rate, defined as CR, PR, or stable disease for at least 6 months', 'timeFrame': '2 years', 'description': 'Parts 1, 2, 3, 4, and 5'}, {'measure': 'Estimates of selected pharmacokinetics (PK ) parameters for SBT6050', 'timeFrame': '2 years', 'description': 'Cmax: Parts 1, 2, 3, 4, and 5'}, {'measure': 'Estimates of selected pharmacokinetics (PK ) parameters for SBT6050', 'timeFrame': '2 years', 'description': 'AUC: Parts 1, 2, 3, 4, and 5'}, {'measure': 'Incidence of antidrug antibodies (ADA) to SBT6050', 'timeFrame': '2 years', 'description': 'Parts 1 and 2'}, {'measure': 'Progression free survival', 'timeFrame': '2 years', 'description': 'Parts 2, 4, and 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2', 'ERBB2', 'Immunotherapy', 'Gastric Cancer', 'Gastroesophageal junction', 'Breast Cancer', 'Triple Negative Breast Cancer', 'Stomach Cancer', 'Colorectal Cancer', 'Gastrointestinal Cancer', 'Non-Small Cell Lung Cancer', 'Monoclonal antibody', 'TLR8', 'TLR8 agonist', 'Antibody drug conjugate', 'Biliary tract cancer', 'Head and neck cancer', 'Urothelial cancer', 'Endometrial cancer', 'Pembrolizumab', 'Anti-PD-1 mAb', 'Cemiplimab'], 'conditions': ['HER2 Positive Solid Tumors']}, 'descriptionModule': {'briefSummary': 'A first-in-human (FIH) study using SBT6050 and SBT6050 in combination with PD-1 inhibitors in HER2 expressing or amplified advanced malignancies', 'detailedDescription': 'This study has 5 parts. Part 1 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 to estimate the maximum tolerated dose (MTD) and determine the dose recommended for Part 2. Part 2 of the study will further evaluate SBT6050 in select HER2 expressing or amplified advanced malignancies.\n\nPart 3 will evaluate the safety, tolerability, and activity of escalating doses of SBT6050 in combination with pembrolizumab to estimate the MTD and determine the dose recommended for Part 4. Part 4 of the study will further evaluate SBT6050 in combination with pembrolizumab in select HER2 expressing or amplified advanced malignancies.\n\nPart 5 of the study will evaluate the safety, tolerability, and activity of SBT6050 in combination with cemiplimab in select HER2 expressing or amplified advanced malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced or metastatic HER2-expressing (IHC 2+ or 3+) or amplified solid tumor\n* Subjects must have received prior therapies known to confer clinical benefit (unless ineligible or refused to receive)\n* Measurable disease per RECIST 1.1\n* Tumor lesion amenable for biopsy or able to provide tissue from biopsy within last 6 months\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematologic, hepatic, and cardiac function\n\nExclusion Criteria:\n\n* History of allergic reactions to certain components of SBT6050 or similar drugs\n* Untreated brain metastases\n* Active autoimmune disease or a documented history of autoimmune disease or syndrome\n* Human immunodeficiency virus infection, active hepatitis B infection or hepatitis C infection\n* Additional protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT04460456', 'briefTitle': 'A Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced HER2 Expressing Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Silverback Therapeutics'}, 'officialTitle': 'A Phase 1/1B, Open-Label, Dose Escalation and Expansion Study of SBT6050 Alone and in Combination With PD-1 Inhibitors in Subjects With Advanced Solid Tumors Expressing HER2', 'orgStudyIdInfo': {'id': 'SBT6050-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBT6050 Monotherapy', 'description': 'Escalating doses of SBT6050 in Part 1 followed by expansion in Part 2 at the recommended dose determined in Part 1.', 'interventionNames': ['Drug: SBT6050']}, {'type': 'EXPERIMENTAL', 'label': 'SBT6050 and pembrolizumab', 'description': 'Escalating doses of SBT6050 in combination with pembrolizumab in Part 3 followed by expansion in Part 4 at the recommended dose determined in Part 3.', 'interventionNames': ['Drug: SBT6050', 'Drug: pembrolizumab']}, {'type': 'EXPERIMENTAL', 'label': 'SBT6050 and cemiplimab', 'description': 'SBT6050 in combination with cemiplimab in Part 5 at the recommended dose determined in Parts 1 and 3.', 'interventionNames': ['Drug: SBT6050', 'Drug: Cemiplimab']}], 'interventions': [{'name': 'SBT6050', 'type': 'DRUG', 'description': 'Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2', 'armGroupLabels': ['SBT6050 Monotherapy', 'SBT6050 and cemiplimab', 'SBT6050 and pembrolizumab']}, {'name': 'pembrolizumab', 'type': 'DRUG', 'description': '400 mg IV', 'armGroupLabels': ['SBT6050 and pembrolizumab']}, {'name': 'Cemiplimab', 'type': 'DRUG', 'description': '350 mg IV', 'armGroupLabels': ['SBT6050 and cemiplimab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute/Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'The START Center for Cancer Care', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '2109', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Macquarie University Hospital Clinical Trials Unit', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3000', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Breast Cancer Research Centre - WA', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Naomi Hunder, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Silverback Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Silverback Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-07-18', 'type': 'RELEASE'}, {'date': '2022-07-22', 'type': 'UNRELEASE'}, {'date': '2022-07-22', 'type': 'RELEASE'}, {'date': '2023-06-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Silverback Therapeutics'}}}}