Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-28 @ 4:25 PM
Study NCT ID:
NCT05246995
Status:
UNKNOWN
Last Update Posted:
2022-02-18
First Post:
2022-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2023-11-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-02-17', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with DLT', 'timeFrame': '42 days post first dose', 'description': 'Number of patients who experienced a dose-limiting toxicity within the first 42 days after the first dose'}, {'measure': 'Number of patients with treatment related AEs', 'timeFrame': 'Up to 90 days post last dose', 'description': 'Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose'}], 'secondaryOutcomes': [{'measure': 'Number of patients with response', 'timeFrame': 'Every 6 weeks until progressive disease or up to 24 months after treatment, whichever came first', 'description': 'Number of patients with response per RECIST 1.1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 combined with Sintilimab in patients with advanced solid tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion\n\n1. Histologically confirmed, locally advanced unresectable or metastatic tumors.\n2. At least one measurable lesion per RECIST 1.1\n3. Male or female subject at least 18 years old and no more than 75 years old.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.\n5. Must have adequate organ function\n6. Be able to provide archived or fresh tumor tissues Exclusion\n\n1\\. Any anti-tumor treatment with 4 weeks, except anti-CD73 monoclonal antibody. 2. Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.\n\n3\\. Unstable central nervous system netastases 4. Known active autoimmune disease or inflammatory disease 5. Known active infectious disease 6. Other uncontrolled systematic disease that may increase the risk of participating the study'}, 'identificationModule': {'nctId': 'NCT05246995', 'briefTitle': 'A Phase I Study of IBI325 in Patients With Advanced Solid Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Shandong Cancer Hospital and Institute'}, 'officialTitle': 'A Phase I, Open-label, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, Combined With Sintilimab in Patients With Advanced Solid Tumor', 'orgStudyIdInfo': {'id': 'CIBI325Y001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBI325 and Sintilimab combination does-escalation', 'interventionNames': ['Drug: IBI325+Sintilimab']}], 'interventions': [{'name': 'IBI325+Sintilimab', 'type': 'DRUG', 'description': 'IBI325 + sintilimab combination does-escalation Patients will receive IBI325 monotherapy on Cycle 1 Day 1 ,and then receive IBI325 and sintilimab combination until progressive disease, intolerability, or other reasons leading to treatment discontinuation', 'armGroupLabels': ['IBI325 and Sintilimab combination does-escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Li Huijuan', 'role': 'CONTACT', 'email': 'ywb234@126.com', 'phone': '0531-67626073'}, {'name': 'Sun Yuping, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xing Ligang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Province Cancer Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yuping Sun', 'role': 'CONTACT', 'email': 'ywb234@126.com', 'phone': '0531-67626073'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Cancer Hospital and Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the hospital', 'investigatorFullName': 'Jinming Yu', 'investigatorAffiliation': 'Shandong Cancer Hospital and Institute'}}}}