Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:31 AM
Study NCT ID:
NCT05048160
Status:
UNKNOWN
Last Update Posted:
2022-05-09
First Post:
2021-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007262', 'term': 'Infusions, Intravenous'}], 'ancestors': [{'id': 'D061605', 'term': 'Administration, Intravenous'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007263', 'term': 'Infusions, Parenteral'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 272}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-05', 'studyFirstSubmitDate': '2021-08-31', 'studyFirstSubmitQcDate': '2021-09-09', 'lastUpdatePostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AEs', 'timeFrame': 'Up to 28 days post last dose', 'description': 'All the adverse events'}, {'measure': 'ORR', 'timeFrame': '1 Year', 'description': 'Objective Response Rate'}, {'measure': 'DOR', 'timeFrame': '1 Year', 'description': 'Duration of Remission'}, {'measure': 'PFS', 'timeFrame': '1 Year', 'description': 'Progression-Free Survival'}, {'measure': 'DCR', 'timeFrame': '1 Year', 'description': 'Disease Control Rate'}, {'measure': 'OS', 'timeFrame': '1 Year', 'description': 'Overall Survival'}], 'secondaryOutcomes': [{'measure': 'PK Parameters', 'timeFrame': '1 Year', 'description': 'The area under the curve (AUC)'}, {'measure': 'PK Parameters', 'timeFrame': '1 Year', 'description': 'Maximum concentration(Cmax)'}, {'measure': 'PK Parameters', 'timeFrame': '1 Year', 'description': 'Time at which maximum concentration(Tmax)'}, {'measure': 'PK Parameters', 'timeFrame': '1 Year', 'description': 'The half life(T1/2)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Neoplasm']}, 'descriptionModule': {'briefSummary': 'This study is a single arm, non-randomized, open label, multiple doses phase I/II international, multicenter clinical trial to evaluate safety, tolerability, PK/PD, immunogenicity and preliminary efficacy in subjects with advanced malignant neoplasm. The study is consisted of two stages: dose escalation and clinical expansion.\n\nOnly Phase I has been submitted to US FDA,and the protocol number is still the same as 6MW3211-2021-CP101.The US title is : A Phase 1, First-in-Human (FIH), Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 6MW3211 in Patients with Advanced Malignancies .', 'detailedDescription': 'Six cohorts are included in dose escalation stage, at doses of 0.3\\~45 mg/kg, respectively. Safety, tolerability, and dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W), IV.\n\nFrom the first study drug administration, some dosing cycles will be observed for phase I, initial tumor efficacy assessments will be performed at week 7, after that tumor efficacy assessment will be carry out for every 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Men or women, age ≥18.\n* 2.Subjects with advanced malignancy histopathologically and/or cytologically, with at least one evaluable tumor lesion.\n* 3.ECOG PS is 0 or 1.\n* 4.Survival expectation of at least 3 months.\n* 5.Adequate organs and hematopoietic functions\n* 6.Voluntarily signing of informed consent\n\nExclusion Criteria:\n\n* 1.Subjects with brain metastases of clinically active central nervous system (CNS).\n* 2.Subjects that require to take anticoagulants and/or aspirin.\n* 3.Blood transfusion within 2 weeks prior to the first administration of study treatment.\n* 4.Inadequately controlled body cavity effusions.\n* 5.Subjects with active, or have a history and possible recurrence of autoimmune diseases .\n* 6.Have uncontrolled systemic diseases.\n* 7.Subjects who had received anticancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment.\n* 8.Subjects are known to have previously experienced severe allergic reactions to large molecular protein formulations/monoclonal antibodies.\n* 9.Pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT05048160', 'briefTitle': 'A Clinical Study of 6MW3211 Injection in the Treatment of Advanced Malignant Neoplasm', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mabwell (Shanghai) Bioscience Co., Ltd.'}, 'officialTitle': 'Phase I/II Clinical Trial of 6MW3211 Injection to Evaluate Safety, Tolerability, PK/PD, Immunogenicity and Preliminary Efficacy in Subjects With Advanced Malignant Neoplasm.(Only Phase I Has Been Submitted to US FDA)', 'orgStudyIdInfo': {'id': '6MW3211-2021-CP101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '6MW3211', 'description': '* Dosage form: injection\n* Specification: 240 mg / 8 ml/Vial', 'interventionNames': ['Drug: Intravenous Infusion']}], 'interventions': [{'name': 'Intravenous Infusion', 'type': 'DRUG', 'description': 'Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W).', 'armGroupLabels': ['6MW3211']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Zhang, Professor', 'role': 'CONTACT', 'email': 'syner2000@163.com', 'phone': '18017312991'}], 'facility': 'Fudan University Cancer Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jian Zhang, Professor', 'role': 'CONTACT', 'email': 'syner2000@163.com', 'phone': '18017312991'}], 'overallOfficials': [{'name': 'Jian Zhang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University Cancer Hospital of China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mabwell (Shanghai) Bioscience Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}