Ignite Creation Date:
2025-12-24 @ 1:35 PM
Ignite Modification Date:
2025-12-30 @ 4:36 PM
Study NCT ID:
NCT05447195
Status:
UNKNOWN
Last Update Posted:
2022-07-12
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2 Study of CAN008 in Subjects With GBM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C574675', 'term': 'APG101'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study is double-blinded. Except for the non-blinded team, no other participants associated with this study should attempt to learn the treatment group assignment or which study treatment they are receiving.The unblinding of all subjects must be carried out after the database is locked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 117}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-10', 'studyFirstSubmitDate': '2022-06-17', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to 3 years', 'description': 'To evaluate the efficacy of CAN008 plus temozolomide (TMZ) treatment in subjects with newly diagnosed glioblastoma (GBM) during and after radiation therapy'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 5 years', 'description': 'Overall survival (OS)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glioblastoma', 'CAN008', 'APG101'], 'conditions': ['Newly-diagnosed Glioblastoma']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study whose objectives are to evaluate the clinical efficacy and safety of CAN008 plus TMZ during and after radiation therapy in newly-diagnosed subjects with glioblastoma who have undergone surgical excision.', 'detailedDescription': 'This study plans to enroll approximately 117 subjects. Subjects determined as having met inclusion criteria through screening will be randomized into treatment groups (CAN008 + RT + TMZ, 78 subjects) and the control group (placebo + RT + TMZ, 39 subjects) in a ratio of 2:1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 to 70.\n* Newly diagnosed glioblastoma.\n* Tumor excision rate ≥80%.\n* Karnofsky performance score ≥70.\n\nExclusion Criteria:\n\n* Medical history of brain radiation therapy or electric field treatment of tumor.\n* Primary infratentorial glioblastoma, multifocal glioma (≥ 2), or leptomeningeal metastasis.\n* Any malignant tumor (excluding WHO grade I-II low-grade astrocytomas, basal cell carcinoma, and carcinoma in situ).\n* Receiving high-dose hormone therapy.'}, 'identificationModule': {'nctId': 'NCT05447195', 'briefTitle': 'Phase 2 Study of CAN008 in Subjects With GBM', 'organization': {'class': 'INDUSTRY', 'fullName': 'CANbridge Life Sciences Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CAN008 Plus TMZ During and After Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma', 'orgStudyIdInfo': {'id': 'CAN008-G-202'}, 'secondaryIdInfos': [{'id': 'CTR20211888', 'type': 'REGISTRY', 'domain': 'Center For Drug Evaluation, NMPA, China'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAN008', 'description': 'CAN008 IV infusion weekly', 'interventionNames': ['Drug: CAN008']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo IV infusion weekly', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CAN008', 'type': 'DRUG', 'otherNames': ['APG101'], 'description': 'Treatment in this study is divided into four periods. Period 1 (W1-W6) is the triple therapy period in which subjects in both groups will be given CAN008 + RT + TMZ. Period 2 (W7-W10) is the treatment-free (rest) period in which subjects do not receive any study drug/therapy. Period 3 (W11-W58) is the CAN008+TMZ maintenance therapy period in which subjects in both groups are given CAN008+TMZ. Period 4 (after W59) is the monotherapy period in which subjects are given CAN008 IV infusion weekly until disease progression.', 'armGroupLabels': ['CAN008']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Treatment in this study is divided into four periods. Period 1 (W1-W6) is the triple therapy period in which subjects in both groups will be given placebo + RT + TMZ. Period 2 (W7-W10) is the treatment-free (rest) period in which subjects do not receive any study drug/therapy. Period 3 (W11-W58) is the placebo+TMZ maintenance therapy period in which subjects in both groups are given placebo+TMZ. Period 4 (after W59) is the monotherapy period in which subjects are given placebo IV infusion weekly until disease progression.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qionghui Qiu', 'role': 'CONTACT', 'email': 'qionghui.qiu@canbridgepharma.com'}, {'name': 'Fangmin Huang', 'role': 'CONTACT', 'email': 'emma.huang@canbridgepharma.com'}, {'name': 'Wenbin Li, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Tiantan Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qionghui Qiu', 'role': 'CONTACT', 'email': 'qionghui.qiu@canbridgepharma.com', 'phone': '+86 21 52996609', 'phoneExt': '807'}, {'name': 'Fangmin Huang', 'role': 'CONTACT', 'email': 'emma.huang@canbridgepharma.com'}], 'overallOfficials': [{'name': 'Wenbin Li, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CANbridge Life Sciences Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}