Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-30 @ 8:21 PM
Study NCT ID:
NCT04984369
Status:
UNKNOWN
Last Update Posted:
2023-08-21
First Post:
2021-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000726503', 'term': 'CCT239065'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2021-07-27', 'lastUpdatePostDateStruct': {'date': '2023-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-15', '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': ['CRC']}, 'descriptionModule': {'briefSummary': 'An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment'}, '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* Metastatic/recurrent advanced BRAF+ mCRC that have been diagnosed histologically and have failed first line treatment\n* ECOG score 0-1;\n\nExclusion Criteria:\n\n* arm 1 ： Previous treatment with BRAF inhibitors or MEK inhibitors\n* Symptomatic brain or meningeal metastases (unless the patient has been on \\> treatment for 3 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).\n* Active clinical severe infection;\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': 'NCT04984369', 'briefTitle': 'The Efficacy of HLX208 (BRAF V600E Inhibitor) With Cetuximab for Metastatic Colorectal Cancer (mCRC) With BRAF V600E Mutation After First-line Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Henlius Biotech'}, 'officialTitle': 'An Open, Multicenter Phase II Clinical Study to Evaluate Safety and Efficacy of HLX208 (BRAF V600E Inhibitor) Combined With Cetuximab in Patients With Metastatic Colorectal Cancer (mCRC)', 'orgStudyIdInfo': {'id': 'HLX208-mCRC201（BECOMES）'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Never use other BRAF inhibitor therapy', 'description': 'Never use other BRAF inhibitor therapy', 'interventionNames': ['Drug: HLX208', 'Drug: Cetuximab Injection [Erbitux]']}, {'type': 'EXPERIMENTAL', 'label': 'PD after other BRAF inhibitor therapy N=5~40', 'description': 'PD after other BRAF inhibitor therapy', 'interventionNames': ['Drug: HLX208', 'Drug: Cetuximab Injection [Erbitux]']}, {'type': 'EXPERIMENTAL', 'label': 'SD but intolerant after other BRAF inhibitor therapy', 'description': 'SD but intolerant after other BRAF inhibitor therapy', 'interventionNames': ['Drug: HLX208', 'Drug: Cetuximab Injection [Erbitux]']}], 'interventions': [{'name': 'HLX208', 'type': 'DRUG', 'otherNames': ['BRAF V600E inhibitor'], 'description': 'HLX208 450mg bid po OR 600mg bid po OR 900mg bid po', 'armGroupLabels': ['Never use other BRAF inhibitor therapy', 'PD after other BRAF inhibitor therapy N=5~40', 'SD but intolerant after other BRAF inhibitor therapy']}, {'name': 'Cetuximab Injection [Erbitux]', 'type': 'DRUG', 'description': 'Cetuximab 500 mg/m2 IV Q2W', 'armGroupLabels': ['Never use other BRAF inhibitor therapy', 'PD after other BRAF inhibitor therapy N=5~40', 'SD but intolerant after other BRAF inhibitor therapy']}]}, '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'}}}}