Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-25 @ 2:33 PM
Study NCT ID:
NCT05239650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-05-03
First Post:
2022-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722210', 'term': 'HLX07'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2026-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-01', 'studyFirstSubmitDate': '2022-02-07', 'studyFirstSubmitQcDate': '2022-02-13', 'lastUpdatePostDateStruct': {'date': '2022-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'up to 3 years', 'description': 'Objective response rate (assessed by investigator per RECIST V1.1)'}, {'measure': 'PFS', 'timeFrame': ': from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，up to 3 years', 'description': 'Progression-free survival (PFS) (assessed by the investigator per RECIST v1.1 )'}], 'secondaryOutcomes': [{'measure': 'OS', 'timeFrame': 'up to 5 years', 'description': 'Overall Survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CRC']}, 'descriptionModule': {'briefSummary': 'This is An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients with Metastatic Colorectal Cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>=18Y and ≤75Y\n* Good Organ Function\n* Expected survival time ≥ 3 months\n* mCRC that have been diagnosed histologically\n* KRAS/NRAS/BRAF WT verified by PCR or NGS of tumor tissue\n* ECOG score 0-1;\n\nExclusion Criteria:\n\n* HIV infection\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': 'NCT05239650', 'briefTitle': 'Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Henlius Biotech'}, 'officialTitle': 'An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 (Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) + HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) + mFOLFOX6 or HLX07 Monotherapy in Patients With Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'HLX07-mCRC201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A：1L treatment', 'description': 'HLX07 \\* 1000 mg+HLX10\\* 200mg +mFOLFOX6, IV, Q2W', 'interventionNames': ['Drug: HLX07', 'Drug: HLX10', 'Drug: mFOLFOX6']}, {'type': 'EXPERIMENTAL', 'label': 'B：≥2L treatment', 'description': 'HLX07 \\*1000 mg monotherapy,IV, Q2W', 'interventionNames': ['Drug: HLX07']}], 'interventions': [{'name': 'HLX07', 'type': 'DRUG', 'description': '1000mg', 'armGroupLabels': ['A：1L treatment', 'B：≥2L treatment']}, {'name': 'HLX10', 'type': 'DRUG', 'description': '200mg', 'armGroupLabels': ['A：1L treatment']}, {'name': 'mFOLFOX6', 'type': 'DRUG', 'description': 'OXA：85 mg/m2;LV:400 mg/m2；5-FU：400 mg/m2', 'armGroupLabels': ['A：1L treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Peng Junjie', 'role': 'CONTACT', 'email': 'junjiepeng67@163.com', 'phone': ': 86021-64175590'}], 'overallOfficials': [{'name': 'Peng Junjie', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University Affiliated Oncology Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Henlius Biotech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}