Ignite Creation Date:
2025-12-25 @ 1:42 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT05815394
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2023-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
177Lu-labeled NY108 SPECT Imaging in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2023-04-04', 'studyFirstSubmitQcDate': '2023-04-04', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108)', 'timeFrame': '1 year', 'description': 'Biodistribution of 177Lu-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '1 year', 'description': 'Safety will be assessed by evaluation of incidence of adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients voluntarily signed informed consent;\n2. Age 18-75, male;\n3. Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis;\n4. Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive;\n5. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen;\n6. Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria;\n7. An ECOG score of 0-2\n\nExclusion Criteria:\n\n1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;\n2. Patients with severe systemic or localized infections or other serious coexisting diseases;\n3. Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc;\n4. Patients with autoimmune diseases, including rheumatoid, etc;\n5. Inadequately controlled arrhythmias, including atrial fibrillation:\n6. Cardiac insufficiency (New York Heart Association (NYHA) work class criteria);\n7. Uncontrolled hypertension;\n8. Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies;\n9. Subjects positive for syphilis, HBV, HCV, FIIV;\n10. Subjects of childbearing age who are unable to use effective contraceptive devices:\n11. Patients with a history of mental illness or related medical conditions;\n12. Patients who are unable or unavailable for SPECT/CT scanning;\n13. Other subjects who, in the opinion of the investigator, are not suitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT05815394', 'briefTitle': '177Lu-labeled NY108 SPECT Imaging in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital of Jiangnan University'}, 'officialTitle': '177Lu-labeled NY108 SPECT Imaging in Patients', 'orgStudyIdInfo': {'id': 'LS2023013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '177Lu-Anti-PSMA mAbs', 'interventionNames': ['Drug: 177Lu-labeled NY108']}], 'interventions': [{'name': '177Lu-labeled NY108', 'type': 'DRUG', 'description': 'Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.', 'armGroupLabels': ['177Lu-Anti-PSMA mAbs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214000', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunjing Yu', 'role': 'CONTACT', 'email': 'ycj_wxd1978@163.com', 'phone': '15312238622'}], 'facility': 'Affiliated Hospital of Jiangnan University', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}], 'centralContacts': [{'name': 'Chunjing Yu', 'role': 'CONTACT', 'email': 'ycj_wxd1978@163.com', 'phone': '15312238622'}], 'overallOfficials': [{'name': 'Chunjing Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital of Jiangnan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital of Jiangnan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Chunjing Yu', 'investigatorAffiliation': 'Affiliated Hospital of Jiangnan University'}}}}