Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT06551233
Status:
RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-11', 'studyFirstSubmitDate': '2024-04-23', 'studyFirstSubmitQcDate': '2024-08-11', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'up to 12 months', 'description': 'assess the incidence of AE/SAE'}, {'measure': 'RP2D and MTD', 'timeFrame': 'up to 12 months', 'description': 'Determine the recommended phase 2 dose (RP2D) and the maximum tolerated dose (MTD) that may occur.'}], 'secondaryOutcomes': [{'measure': 'DFS rate of 12 months', 'timeFrame': 'Up to 12 months', 'description': 'Disease-free survival rate of 12 months'}, {'measure': 'DoR of CR', 'timeFrame': 'Up to 20 months', 'description': 'Duration of complete response'}, {'measure': 'CR rate of 3/6/12 months', 'timeFrame': 'Up to 12 months', 'description': 'Complete response rate of 3/6/12 months'}, {'measure': 'DFS', 'timeFrame': 'Up to 20 months', 'description': 'Disease-free survival'}, {'measure': 'Duration to radical cystectomy', 'timeFrame': 'Up to 20 months', 'description': 'Duration to radical cystectomy'}, {'measure': 'Proportion of radical cystectomy', 'timeFrame': 'Up to 20 months', 'description': 'Proportion of radical cystectomy'}, {'measure': 'Biomarker parameter', 'timeFrame': 'Up to 20 months', 'description': 'Expression of Nectin-4'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'Assess the safety and efficacy of 9MW2821 in patients with high-risk non-muscle-invasive bladder cancer (NMIBC) who have previously failed to intravesical therapy. Provide a new treatment option for patients with NMIBC recurrence, reduce the risk of tumor recurrence, decrease the rate of radical bladder surgery, and enhance the quality of life for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age≥18 years old before signing the informed consent.\n* Subjects must have previously failed to at least one kind of intravesical therapy, including but not limited to BCG, gemcitabine, etc.\n* Subjects refuse or are intolerant to BCG therapy.\n* Subjects must have completed a standard TURBT surgery within 6 weeks before the first dose of the study drug and have no evidence of residual tumors in the surgical field.\n* Tumor tissue samples from TURBT must be provided (≥5 slides), along with relevant pathological reports.\n* Histological and pathological diagnosis of urothelial carcinoma (with a major component \\>50%) , with the confirmation of no-muscle invasion.\n* Subjects must be categorized as high-risk NMIBC\n* Subjects refuse or are intolerant to radical cystectomy.\n* Clinical non-metastatic bladder cancer (N0, M0) determined by CT scan.\n* Adequate function of heart, bone marrow, liver, and kidney.\n* ECOG 0-1\n* Subjects must be willing to take highly effective contraception during the study and 180 days after the last dose of 9MW2821 (a negative serum pregnancy test result within ≤7 days before enrollment for the female).\n\nExclusion Criteria:\n\n* History of muscle invasive or metastatic bladder cancer.\n* History of other malignancies within 3 years.\n* Other systemic anti-cancer therapies within 3 weeks before the first dose of the study drug.\n* Surgery (such as TURBT) or radiotherapy for bladder lesions within 2 weeks before the first dose.\n* Hypersensitivity reactions to certain components of 9MW2821 or similar drugs.\n* Persistence of adverse reactions caused by prior anti-tumor therapy before the first dose, does not recover to grade 1 and below, according to NCI-CTCAE v5.0.\n* Active systemic infections that require treatments within 7 days before the first dose.\n* Severe cardiovascular diseases within 6 months before the first dose.\n* History of allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* History of autoimmune diseases.\n* Serum virology tests: positive results for HBsAg or HBcAb, with positive HBV-DNA copies (≥500IU/mL); positive HCV-Ab results, with positive HCV-RNA results; positive HIV-Ab results.\n* Prior treatment with drugs targeted Nectin-4 or MMAE-conjugated ADC.'}, 'identificationModule': {'nctId': 'NCT06551233', 'briefTitle': 'Safety and Efficacy of 9MW2821 in the Treatment of High-risk Non-muscle-invasive Bladder Cancer (NMIBC)', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'A Clinical Study on the Safety and Efficacy of 9MW2821 in Patients With High-risk Non-muscle-invasive Bladder Cancer (NMIBC) That Have Previously Failed to Intravesical Therapy', 'orgStudyIdInfo': {'id': 'IUNU-UC-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose escalation and expansion', 'description': 'Induction period: once a week, 6 times in total. Maintenance period: once per 28 days, 9 times in total. Intravesical therapy', 'interventionNames': ['Drug: 9MW2821']}], 'interventions': [{'name': '9MW2821', 'type': 'DRUG', 'description': 'Patients will be evaluated from low dose to high dose through intravesical therapy and then select the suitable doses to expand according to study data.', 'armGroupLabels': ['dose escalation and expansion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo Hongqian, PhD', 'role': 'CONTACT', 'email': 'dr.ghq@nju.edu.cn', 'phone': '8613605171690'}], 'facility': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Guo Hongqian, PhD', 'role': 'CONTACT', 'email': 'dr.ghq@nju.edu.cn', 'phone': '8613605171690'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hongqian Guo', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}