Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT02900157
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2016-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-13', 'studyFirstSubmitDate': '2016-09-02', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects reporting infusion related reactions', 'timeFrame': 'First dose of study medication through 30 days after the first dose of study medication'}, {'measure': 'Number of subjects that develop changes in detectable antidrug antibodies to MEDI9090', 'timeFrame': 'First dose of study medication through 6 months after the last dose of study medication'}], 'secondaryOutcomes': [{'measure': 'Individual MEDI9090 concentrations', 'timeFrame': 'First dose of study medication through 3 months after the last dose of study medication'}, {'measure': 'Number of subjects reporting adverse events', 'timeFrame': 'Screening through 3 months after last dose of study medication'}, {'measure': 'Number of subjects reporting serious adverse events', 'timeFrame': 'Screening through 3 months after the last dose of study medication'}, {'measure': 'Number of subjects with vital sign abnormalities reported as adverse events', 'timeFrame': 'Screening through 3 months after the last dose of study medication'}, {'measure': 'Number of subjects with ECG abnormalities reported as adverse events', 'timeFrame': 'Screening through 3 months after the last dose of study medication'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Advanced Solid Tumor', 'Immunotherapy', 'MEDI9090', 'MEDI4736', 'Durvalumab'], 'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is an open-label, study of MEDI9090 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of MEDI9090 in adult subjects with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects\n* 18 years and older\n* Must have histologic documentation of advanced solid tumors\n* Must have received and have progressed, are refractory or, intolerant to standard therapy and must not have a curative therapy option\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study\n* Prior participation in clinical studies that include durvalumab alone or in combination\n* Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment'}, 'identificationModule': {'nctId': 'NCT02900157', 'briefTitle': 'Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedImmune LLC'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI9090 in Subjects With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'D4190C00055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MEDI9090', 'interventionNames': ['Biological: MEDI9090', 'Biological: Durvalumab']}], 'interventions': [{'name': 'MEDI9090', 'type': 'BIOLOGICAL', 'description': 'MEDI9090 will be administered by IV infusion', 'armGroupLabels': ['MEDI9090']}, {'name': 'Durvalumab', 'type': 'BIOLOGICAL', 'description': 'Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.', 'armGroupLabels': ['MEDI9090']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '135-8550', 'city': 'KÅtoku', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 42.50417, 'lon': 143.14297}}, {'zip': '003-0804', 'city': 'Sapporo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '411-8777', 'city': 'Sunto-gun', 'country': 'Japan', 'facility': 'Research Site'}], 'overallOfficials': [{'name': 'MedImmune LLC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MedImmune LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}