Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT05867420
Status:
RECRUITING
Last Update Posted:
2023-09-07
First Post:
2023-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2023-05-04', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose limiting toxicities (DLTs)', 'timeFrame': '21days', 'description': 'To evaluate the safery of ASKG915 in subjects.'}, {'measure': 'Adverse events(AEs)', 'timeFrame': '21days', 'description': 'To evaluate the safery of ASKG915 in subjects.'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': '21days', 'description': 'To evaluate the systemic pharmacokinetics of ASKG915 in subjects.'}, {'measure': 'Area under the concentration time curve (AUC)', 'timeFrame': '21days', 'description': 'To evaluate the systemic pharmacokinetics of ASKG915 in subjects.'}, {'measure': 'Plasma clearance rate (CL)', 'timeFrame': '21days', 'description': 'To evaluate the systemic pharmacokinetics of ASKG915 in subjects.'}, {'measure': 'Evaluation of immunogenicity', 'timeFrame': 'Up to 2 years from date of treatment start until data cut-off', 'description': 'Incidence of anti-drug antibodies (ADA)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The study is a Phase 1dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of ASKG915 as a single agent in patients with selected advanced solid tumors.', 'detailedDescription': 'A two-part, dose-escalation and expansion study of ASKG915 was initiated to determine the safety, tolerability, PK and PD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.\n2. ECOG performance status of ≤ 2.\n3. Life expectancy of ≥ 3 months.\n4. The results of the laboratory tests must meet all criteria.\n\nExclusion Criteria:\n\n1. Patients have received antitumor therapy during the first 4 weeks before study drug use.\n2. Received a live attenuated vaccine within 4 weeks prior to C1D1.\n3. Known cerebral parenchymal metastasis or meningeal metastasis.\n4. History of serious cardiovascular or cerebrovascular diseases.\n5. Active or recurrent autoimmune diseases.\n6. History of ascites or pleural effusion requiring drainage.\n7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.'}, 'identificationModule': {'nctId': 'NCT05867420', 'briefTitle': 'A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AskGene Pharma, Inc.'}, 'officialTitle': 'A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 as a Single Agent in Patients With Selected Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'ASKG915-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASKG915', 'description': 'Single or multiple ascending dose of ASKG915.', 'interventionNames': ['Biological: ASKG915']}], 'interventions': [{'name': 'ASKG915', 'type': 'BIOLOGICAL', 'description': 'ASKG915 is administered intravenously at a fixed dose. The drug was given once every 3 weeks for a cycle.', 'armGroupLabels': ['ASKG915']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Stein, MD', 'role': 'CONTACT'}], 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jason Luke, MD', 'role': 'CONTACT'}], 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Chief Medical Officer', 'role': 'CONTACT', 'email': 'barbara.hickingbottom@ask-gene.com', 'phone': '805-389-2956'}, {'name': 'Executive Director, Clinical Operations', 'role': 'CONTACT', 'email': 'jennifer.ely@ask-gene.com', 'phone': '805-389-2956'}], 'overallOfficials': [{'name': 'Barbara Hickingbottom, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ask-Gene Pharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AskGene Pharma, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Jiangsu Aosaikang Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}