Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-25 @ 4:50 PM
Study NCT ID:
NCT05114603
Status:
UNKNOWN
Last Update Posted:
2022-05-03
First Post:
2021-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-01', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'from first dose to the last patient was followed up for 6 month', 'description': 'Objective response rate(assessed by independent radiological review committee (IRRC) based on the e 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 1 years', 'description': 'Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1'}, {'measure': 'DOR', 'timeFrame': 'from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years', 'description': 'Duration of response'}, {'measure': 'OS', 'timeFrame': 'from the first dose to the time of death due to any cause，assessed up to 2 years', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Melanoma']}, 'descriptionModule': {'briefSummary': 'An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>=18Y\n* Good Organ Function\n* Expected survival time ≥ 3 months\n* advanced melanoma with BRAF V600 mutation that have been diagnosed\n* ECOG score 0-1;\n\nExclusion Criteria:\n\n* Previous treatment with BRAF inhibitors or MEK inhibitors\n* Symptomatic brain or meningeal metastases (unless the patient has beenon \\> treatment for 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable).\n* Severe active infections requiring systemic anti-infective therapy\n* A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.'}, 'identificationModule': {'nctId': 'NCT05114603', 'briefTitle': 'A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Henlius Biotech'}, 'officialTitle': 'An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation', 'orgStudyIdInfo': {'id': 'HLX208-MEL201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose-escalation stage', 'description': 'Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding.', 'interventionNames': ['Drug: HLX208']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-expansion stage', 'description': 'Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208.', 'interventionNames': ['Drug: HLX208']}], 'interventions': [{'name': 'HLX208', 'type': 'DRUG', 'description': 'level 1:600mg po Bid level 2:900mg po Bid', 'armGroupLabels': ['Dose-escalation stage', 'Dose-expansion stage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Si, MD PhD', 'role': 'CONTACT', 'email': 'silu15_silu@126.com'}], 'facility': 'Peking University Cancer Hospita', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingxiang Pu', 'role': 'CONTACT', 'email': 'puxingxiang@hnca.org.cn'}], 'facility': 'Hunan cancer hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chendu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiyan Liu', 'role': 'CONTACT', 'email': 'liujiyan1972@163.com'}], 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.92504, 'lon': 121.03163}}, {'city': 'Fujian', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu Chen', 'role': 'CONTACT', 'email': '13859089836@136.com'}], 'facility': 'Fujian cancer hospital', 'geoPoint': {'lat': 28.92651, 'lon': 106.12972}}, {'city': 'Taiyuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Huijing feng', 'role': 'CONTACT'}], 'facility': 'Shangxi Bethune Hospita', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Wuhan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Chen', 'role': 'CONTACT', 'email': 'bswhunion@163.com'}], 'facility': 'union Hospital Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Zhengzhou', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weitao Yao', 'role': 'CONTACT', 'email': 'ywtwhm@163.com'}], 'facility': 'Henan cancer hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Jun Guo', 'role': 'CONTACT', 'email': 'guoj307@126.com', 'phone': '88196391'}, {'name': 'Lu Si', 'role': 'CONTACT', 'email': 'silu15_silu@126.com', 'phone': '88196391', 'phoneExt': '88196391'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Henlius Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}