Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT03638804
Status:
UNKNOWN
Last Update Posted:
2018-12-05
First Post:
2018-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-04', 'studyFirstSubmitDate': '2018-07-23', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Maximum serum concentration of 89Zr-KN035 (Cmax)', 'timeFrame': '6 months', 'description': 'Blood samples will be collected and assessed by timepoints.'}, {'measure': 'Time to Maximum Concentration of 89Zr-KN035 (Tmax)', 'timeFrame': '6 months', 'description': 'Blood samples will be collected and assessed by timepoints.'}, {'measure': 'Calculation of radiation dosimetry of 89Zr-KN035', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'Description of regions of interest (ROI) 89Zr-KN035 by measuring standardized uptake value (SUV) on 89Zr-KN035 PET scans', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Number of adverse events as assessed by CTCAE v4.03', 'timeFrame': '6 months', 'description': 'All adverse events will be assessed by CTCAE v 4.03 and evaluated if treatment-related or not.'}, {'measure': 'Number of changes in laboratory test results as accessed by CTCAE v4.03', 'timeFrame': '6 months', 'description': 'Laboratory tests (blood, urine) will be conducted by time. Significant changes will be assessed by CTCAE v 4.03.'}, {'measure': 'Number of changes in vital signs as accessed by CTCAE v4.03', 'timeFrame': '6 months', 'description': 'Vital signs (heart rate, respiratory rate, blood pressures and body temperature) data will be collected by time. Significant changes will be assessed by CTCAE v4.03.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['89Zr', 'PD-L1', 'KN035', 'PET'], 'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': 'This is a single arm study by using 89Zr-labeled KN035 (89Zr-KN035) PET imaging to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors.', 'detailedDescription': 'The overall purpose of the study is to evaluate the biodistribution and target lesion uptake of 89Zr-KN035 in patients with PD-L1 positive advanced solid tumors by using PET imaging. Safety will be observed after 89Zr-KN035 injection, and radiation dosimetry of 89Zr-KN035 will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (main):\n\n1. Patients voluntarily signed informed consent;\n2. Age 18-75, male or female;\n3. Patients diagnosed with locally advanced or metastatic solid tumors by histopathology or cytology;\n4. Patients with biopsy-proven PD-L1 positive;\n5. ECOG score ≤ 0\\~1; Life expectancy of at least 3 months;\n6. Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects.\n\nExclusion Criteria(main):\n\n1. Currently or within the first 28 days before the first dose to participate in another therapeutic clinical trial. If participating in a non-interventional clinical trial, it is not be excluded.\n2. Patients with systemic or locally severe infections (CTCAE ≥ 2);\n3. Patients with allergies or allergies to any component of the imaging agent or antibody;\n4. Patients who cannot undergo PET/CT imaging;\n5. Intolerance of intravenous administration, as well as difficulties in venous blood collection (If having the medical history of fainting during acupuncture, and blood phobia);\n6. Symptomatic congestive heart failure (NYHA class II-IV) or symptomatic or poorly controlled arrhythmia;\n7. Patients have significant QT/QTC interval prolongation during the screening period;\n8. Received anti-tumor therapy (including but not limited to chemotherapy, radiotherapy, biological therapy) within 4 weeks prior to first dose;\n9. Patents have not recovered to CTCAE grade 0 or 1 from the adverse events due to cancer therapeutics administered;\n10. Previously received CD137 agonist or immune checkpoint blocking therapy;\n11. Patients with diabetes who have a fasting blood glucose greater than 10 mmol/L;\n12. HIV antibody positive, active hepatitis B/C, and TB positive;\n13. Patients are regular users (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol);\n14. Patients with symptomatic ascites, pleural effusion, or hydropericardium;\n15. Pregnant or lactating women, or planning to become pregnant or have children during this trial.'}, 'identificationModule': {'nctId': 'NCT03638804', 'briefTitle': '89Zr-KN035 PET Imaging in Patients With Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': '89Zr-labeled KN035 PET Imaging in Patients With PD-L1positive Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'AMS-2017-007-a'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '89Zr-KN035 injection', 'interventionNames': ['Diagnostic Test: 89Zr-KN035']}], 'interventions': [{'name': '89Zr-KN035', 'type': 'DIAGNOSTIC_TEST', 'description': 'Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.', 'armGroupLabels': ['89Zr-KN035 injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yicong Bian', 'role': 'CONTACT', 'email': 'bianyicong@126.com', 'phone': '86 0512 6778 0467'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Hua Zhang', 'role': 'CONTACT', 'email': 'sdfyy8040@126.com', 'phone': '86 0512 6778 0040'}, {'name': 'Yicong Bian', 'role': 'CONTACT', 'email': 'bianyicong@126.com', 'phone': '86 0512 6778 0467'}], 'overallOfficials': [{'name': 'Liyan Miao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}, {'name': 'Jianan Huang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'collaborators': [{'name': 'MITRO Biotech Co., Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Miao Liyan', 'investigatorAffiliation': 'The First Affiliated Hospital of Soochow University'}}}}