Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 12:18 AM
Study NCT ID:
NCT05102292
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2021-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065646', 'term': 'Thyroid Carcinoma, Anaplastic'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000726503', 'term': 'CCT239065'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2021-10-20', 'studyFirstSubmitQcDate': '2021-10-20', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to 2 years', 'description': 'Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)'}], 'secondaryOutcomes': [{'measure': 'PFS', 'timeFrame': 'from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years', 'description': 'Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )'}, {'measure': 'OS', 'timeFrame': 'from the date of first dose until the date of death from any cause，assessed up to 2 years', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anaplastic Thyroid Cancer', 'ATC']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess efficacy, safety and PK in anaplastic thyroid cancer (ATC) given HLX208 (BRAF V600E inhibitor).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age\\>=18Y;\n2. Good Organ Function;\n3. Expected survival time ≥ 3 months;\n4. Advanced BRAF V600 ATC that have been diagnosed histologically;\n5. At least one measurable lesion as per RECIST v1.1;\n6. ECOG score 0-1.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Previous treatment with BRAF inhibitors or MEK inhibitors;\n3. A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin;\n4. Severe active infections requiring systemic anti-infective therapy.'}, 'identificationModule': {'nctId': 'NCT05102292', 'briefTitle': 'The Efficacy and Safety of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Henlius Biotech'}, 'officialTitle': 'An Open Label, Multicenter Phase Ib/II Clinical Study to Evaluate Efficacy , Safety and PK of HLX208 in Advanced Anaplastic Thyroid Cancer (ATC) With BRAF V600 Mutation', 'orgStudyIdInfo': {'id': 'HLX208-ATC201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HLX208', 'description': 'Participants receive HLX208 450mg bid po', 'interventionNames': ['Drug: HLX208']}], 'interventions': [{'name': 'HLX208', 'type': 'DRUG', 'otherNames': ['BRAF V600E inhibitor'], 'description': 'HLX208 450mg bid po', 'armGroupLabels': ['HLX208']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Fudan University Affiliated Oncology Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Henlius Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}