Ignite Creation Date:
2025-12-24 @ 2:20 PM
Ignite Modification Date:
2026-01-07 @ 4:46 PM
Study NCT ID:
NCT06389695
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2024-04-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-04-24', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events', 'timeFrame': '5 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '39745526', 'type': 'DERIVED', 'citation': 'Fu H, He H, Wang Y, Li W, Luo Y, Chen L, Mi Y, Sun C, Mao Y, Yu C. Preliminary evaluation of a novel PSMA-targeting radiopharmaceutical [68Ga]Ga/[177Lu]Lu-NYM032 for theranostic use in prostate cancer. Eur J Nucl Med Mol Imaging. 2025 Apr;52(5):1671-1684. doi: 10.1007/s00259-024-07046-5. Epub 2025 Jan 2.'}]}, 'descriptionModule': {'briefSummary': '68Ga-NYM032 is a PSMA-targeting small-molecular radiotracer for PET/CT imaging of prostate cancer, which is needed for clinical trial to be conducted'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with pathologically confirmed prostate cancer;\n2. Age range from 18 to 75 years old (including 18 and 75 years old);\n3. ECOG score of 0 or 1;\n4. Expected life ≥ 6 months；\n5. The subjects agree to take effective contraceptive measures during the study period and for at least three months after the diug administration;\n6. The subjects are able to maintain good communication with the researchers；understand and follow the requirements of this study and sign an informed consent form before the start of relevant research operations.\n\nExclusion Criteria:\n\n1. Known or suspected to be allergic to the investigational drug or any of its components;\n2. Accepting other investigational drugs upon enrollment, or within 5 biological half-lives of the drug at enrollment, or within 30 days after its last administration, whichever is longer;\n3. Those who have used any radioactive therapy medication within 90 days before investigational drug administration, or have received any radioactive diagnostic medication within 3 days before investigational drug administration;\n4. Planned androgen deprivation therapies use, any therapeutic intervention for the prostate cancer and use of folate supplements during the study;\n5. Plan to arrange surgery and other invasive interventions within 2 days after the injection of the investigational drug；\n6. Ongoing toxicity \\>grade l from previous standard or investigational therapies；\n7. Patients with active infections during screening;\n8. Those who have no guarantee of being able to lie down quietly in the examination cabin during a PET examination, or those who suffer from claustrophobia and cannot cooperate in a PET examination:\n9. Other situations where the researchers believe that the subject is not suitable for inclusion in this study.'}, 'identificationModule': {'nctId': 'NCT06389695', 'briefTitle': 'Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of 68Ga-NYM032 in Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Norroy Bioscience Co., LTD'}, 'officialTitle': 'Pharmacokinetics, Biodistribution, Radiation Dose and Safety Study of a Single Dose of Gallium [68Ga]-NYM032 Injection Prepared by Kit for the Preparation of the 68Ga-NYM032 Injection in Patients With Prostate Cancer', 'orgStudyIdInfo': {'id': 'CP-2023-03'}, 'secondaryIdInfos': [{'id': 'NYM032D01', 'type': 'OTHER', 'domain': 'National Medical Products Administration'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '68Ga-NYM032 injection', 'interventionNames': ['Drug: 68Ga-NYM032 injection']}], 'interventions': [{'name': '68Ga-NYM032 injection', 'type': 'DRUG', 'description': 'The radiation dose is about 3-6 mCi for a single patient.Using a syringe to withdraw 68Ga-NYM032 injection, the dose will be administered via an intravenous injection and the injection time will be about 45-60 seconds.', 'armGroupLabels': ['68Ga-NYM032 injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214000', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Affliated Hospital of Jiangnan University', 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norroy Bioscience Co., LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}