Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-31 @ 5:36 AM
Study NCT ID:
NCT05263869
Status:
UNKNOWN
Last Update Posted:
2022-12-02
First Post:
2022-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MRG002 in Treatment of Advanced HER-2 Positive Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 99}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-29', 'studyFirstSubmitDate': '2022-02-21', 'studyFirstSubmitQcDate': '2022-03-01', 'lastUpdatePostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) by Independent Review Committee (IRC)', 'timeFrame': 'Baseline to study completion (up to 12 months）', 'description': 'ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR) assessed by IRC according to RECIST v1.1.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) by Investigator', 'timeFrame': 'Baseline to study completion (up to 12 months)', 'description': 'ORR is defined as the proportion of subjects with CR and PR assessed by investigator according to RECIST v1.1.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Baseline to study completion (up to 12 months)', 'description': 'DOR is defined as the duration from the initial recording of objective disease response to the first onset of tumor progression, or death of any cause.'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Baseline to study completion (up to 12 months)', 'description': 'CBR is defined as the proportion of subjects with CR, PR and stable disease (SD) ≥ 6 months after treatment.'}, {'measure': 'Time to Response (TTR)', 'timeFrame': 'Baseline to study completion (up to 12 months)', 'description': 'TTR is defined as the time from the start of treatment until the first occurrence of CR or PR by tumor assessment.'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'Baseline to study completion (up to 12 months)', 'description': 'DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Baseline to study completion (up to 12 months)', 'description': 'PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline to study completion (up to 12 months)', 'description': 'OS is defined as the duration from the start of treatment to death of any cause.'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'Baseline to 30 days after the last dose of study treatment', 'description': 'Any reaction, side effect, or untoward event that occurs during the course of the clinical trial whether or not the event is considered related to the study drug.'}, {'measure': 'PK parameters: concentration-time curve', 'timeFrame': 'Baseline to 14 days after decision to discontinue treatment', 'description': 'Plot of drug concentration changing with time after drug administration.'}, {'measure': 'Immunogenicity (ADA)', 'timeFrame': 'Baseline to 14 days after decision to discontinue treatment', 'description': 'The proportion of patients with positive ADA results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRG002', 'Antibody Drug Conjugate (ADC)', 'HER2'], 'conditions': ['Breast Cancer With Liver Metastases']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2 positive breast cancer with liver metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing to sign the informed consent form and follow the requirements specified in the protocol.\n2. Aged 18 to 75 (including 18 and 75), both genders; Life expectancy ≥ 12 weeks;\n3. The score of ECOG for performance status is 0 or 1\n4. Patients with HER2-positive breast cancer confirmed by central laboratory and with evidence of liver metastasis by imaging;\n5. Archival or biopsy tumor specimens should be provided (primary or metastatic) for HER2 testing;\n6. Patients must have measurable lesions according to the Response Criteria in Solid Tumors (RECISTv1.1);\n7. Organ functions must meet the basic requirements.\n8. Patients of childbearing potential are willing to take effective contraceptive measures from the time of signing the informed consent form to 6 months after last administration of the study drug.\n\nExclusion Criteria:\n\n1. Previous history of other primary malignancies;\n2. Presence of peripheral neuropathy ≥ grade 2 (according to CTCAE V5.0);\n3. Previously received antibody-drug conjugates, investigational drugs, anti-tumor vaccines or drugs, endocrine therapy for breast cancer, radiotherapy, CYP3A4 inhibitors or inducers, anthracyclines and other treatments;\n4. Central nervous system metastasis and/or neoplastic meningitis;\n5. History of decompensated cirrhosis, or liver metastases with a single lesion ≥ 10 cm in longest diameter;\n6. Pleural or peritoneal effusion with combined clinical symptoms, which seriously endangers the life safety of subjects or urgently requires clinical treatment; Or pericardial effusion with combined clinical symptoms;\n7. Any serious or uncontrolled systemic disease judged by the investigator;\n8. Uncontrolled cardiac disease;\n9. Evidence of active infection;\n10. Pulmonary embolism or deep venous thrombosis within 3 months prior to study treatment;\n11. History of interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary dysfuction, symptomatic bronchospasm, etc.;\n12. Patients with active autoimmune disease or a history of autoimmune diseases who are receiving immunosuppressive agents or systemic hormone therapy, and are still using them within 2 weeks prior to enrollment;\n13. History of hypersensitivity to any component of MRG002 or known history of hypersensitivity of ≥ Grade 3 to trastuzumab injection;\n14. Uncontrolled tumor-related bone pain or urgent spinal cord compression;\n15. Other conditions inappropriate for participation in this study, as deemed by the investigator.'}, 'identificationModule': {'nctId': 'NCT05263869', 'briefTitle': 'A Study of MRG002 in Treatment of Advanced HER-2 Positive Breast Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Miracogen Inc.'}, 'officialTitle': 'An Open-label, Multi-center, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of MRG002 in Advanced HER-2 Positive Breast Cancer Patients Previously Treated With Trastuzumab and TKIs (Magic-009)', 'orgStudyIdInfo': {'id': 'MRG002-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRG002', 'description': 'MRG002 will be administrated via intravenous infusion of 2.6 mg/kg once on Day 1 of every 3 weeks (21-day cycle).', 'interventionNames': ['Drug: MRG002']}], 'interventions': [{'name': 'MRG002', 'type': 'DRUG', 'description': 'Administrated intravenously', 'armGroupLabels': ['MRG002']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zefei Jiang, Doctor', 'role': 'CONTACT', 'email': 'jiangzefei@csco.cog.cn', 'phone': '13901372170'}], 'facility': 'Fifth Medical Center of PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '510300', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiang Liu, Doctor', 'role': 'CONTACT', 'email': 'liuqiang_ng_sysu@163.com', 'phone': '18922182851'}], 'facility': 'Sun Yat-sen Memorial Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Program Director', 'role': 'CONTACT', 'email': 'clinicaltrials@miracogen.com.cn', 'phone': '86-21-61637960'}], 'overallOfficials': [{'name': 'Zefei Jiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fifth Medical Center of PLA General Hospital'}, {'name': 'Qiang Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Miracogen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}