Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT04864418
Status:
UNKNOWN
Last Update Posted:
2023-07-20
First Post:
2021-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AST-021p Study in 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': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 19}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-18', 'studyFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by AST-021p', 'timeFrame': '6weeks after AST-021p administration in each cohort group', 'description': 'After AST-021p administration in patients with advance solid tumor, safety and tolerance are assessed for each dose group(1.2mg,2.4mg, 3.6mg \\&4.8mg)\n\nSafety and tolerance evaluation variables :\n\n1)adverse events 2) Vital signs 3)Physical examination 4) ECOG performance evaluation 5)ECG examination 6)Laboratory examination'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity assessment', 'timeFrame': '8weeks after ASP-021p administration (Priming immunization case) or 20weeks after ASP-021p(Priming immunization and Boosting immunization case)', 'description': 'ASP-021p specific IFN-γ ELISpot(Interferon Gamma Enzyme-linked immunospot) test results and ASP-021p4 \\& ASP-021p5 specific IFN-γ ELISpot ( spots/250,000 Tcell of pre ASP-021p and post ASP-021p)'}, {'measure': 'Tumor response assessment', 'timeFrame': 'Overall study period approximately up to 5months', 'description': 'Disease control rate (%), objective response rate(%) and duration of response (days \\& weeks)'}, {'measure': 'Progression-Free Survival rate', 'timeFrame': 'Overall study period approximately up to 5months', 'description': 'PFS rate (%) at End of Study'}, {'measure': 'Overall Survival rate', 'timeFrame': 'Overall study period approximately up to 5months', 'description': 'OS rate (%) at End of study'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cancer vaccine'], 'conditions': ['Advanced Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability and optimal Immunogenic dose of therapeutic cancer vaccine (AST-021p) in patients With advanced solid tumors\n\nA phase 1 study', 'detailedDescription': 'Recurrent or advanced solid cancer patients without applicable standard treatments will be included in the 4 dose groups (4 cohort groups- 1.2mg, 2.4mg,3.6mg and 4.8mg) of AST-021p. Participants in each cohort group will be treated 3 times in each dose (3 priming immunications)\n\nThis study will apply a modified 3+3 design for dose-escalation.\n\n1 participant will be registered in the lowest dose cohort group(1.2mg) and when the safety and tolerance of the AST-021p(1.2mg) are identified in the the first group, dose will be increased sequentially and accordingly, the safety and tolerance will be assessed for six participants in the other cohort groups (group2(2.4mg), group3(3.6mg) and group4(4.8mg)).\n\nParticipants receiving priming immunization only will be assessed up to End of Treatment(EOT) and participants who recive boosting immunization will be evaluated until the end of study(EOS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* has recurrent or metastatic solid cancer that has been proven histologically or cytologically and cannot be treated with surgery or radiotherapy for the purpos of complete remission\n* does not have a standard treatment that can be applied clinically according to the investigator's judgment\n* has an expected life expectancy of more than 3 months\n* adults aged 19 or older based on screening day\n* ECOG performance status : 0\\~1\n\nExclusion Criteria:\n\n* Has a history of hypersensitivity or other contraindications to rhGM-CSF and Montanide ISA 51 VG\n* Has a history of other primary malignant tumor\n* Has autoimmune diseases or inflammatory diseases\n* Has a history of active primary immunodeficiency disease\n* Has active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection\n* Is pregnant or breastfeeding or expecting to conceive children\n* has a history of immune suppression therapy ≤4 weeks prior to the screening day"}, 'identificationModule': {'nctId': 'NCT04864418', 'briefTitle': 'AST-021p Study in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aston Sci. Inc.'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety, Tolerability and Optimal Immunogenic Dose of Therapeutic Cancer Vaccine (AST-021p) in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'PN-021-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort group of AST-021p for dose-escalation', 'description': '4 cohort groups for AST- 021p administration:\n\nGroup 1) 1.2mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF\n\nGroup 2) 2.4mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF\n\nGroup 3) 3.6mg AST-021p, Montanide ISA 51 VG and rhuGM-CSF\n\nGroup 4) 4.8mg AST- 021p, Montanide ISA 51 VG and rhuGM-CSF', 'interventionNames': ['Drug: AST-021p']}], 'interventions': [{'name': 'AST-021p', 'type': 'DRUG', 'description': '3 priming immunization (2weeks x3) in 4 cohort groups (1.2mg, 2.4mg, 3.6mg and 4.8mg AST-021p) if possible, 3 boosting immunization (4weeks x 3) in cohort groups after priming immunization', 'armGroupLabels': ['Cohort group of AST-021p for dose-escalation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul ST. Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyong Hwa Park, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University Anam Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aston Sci. Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}