Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT05172856
Status:
UNKNOWN
Last Update Posted:
2021-12-29
First Post:
2021-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With 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': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2021-12-23', 'studyFirstSubmitQcDate': '2021-12-23', 'lastUpdatePostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.', 'timeFrame': 'From Baseline until disease progression (up to 2 years)'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS), According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 evaluated by investigators.', 'timeFrame': 'From Baseline until disease progression (up to 2 years)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From Day 1 to up to 2 years'}, {'measure': 'Percentage of Participants with Adverse Events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0', 'timeFrame': 'From Day 1 to up to 2 years'}, {'measure': 'Area Under the Concentration-Time Curve (AUC) of IBI321', 'timeFrame': 'From Day 1 up to 2 years'}, {'measure': 'Maximum Serum Concentration (Cmax) of IBI321', 'timeFrame': 'From Day 1 up to 2 years'}, {'measure': 'Minimum Serum Concentration (Cmin) of IBI321', 'timeFrame': 'From Day 1 up to 2 years'}, {'measure': 'Clearance (CL) of IBI321', 'timeFrame': 'From Day 1 up to 2 years'}, {'measure': 'Percentage of Participants with Anti-Drug Antibodies (ADAs) to IBI321', 'timeFrame': 'From Day 1 up to 2 years'}, {'measure': 'Percentage of Participants with Neutralizing Antibody (Nab) to IBI321', 'timeFrame': 'From Day 1 up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'descriptionModule': {'briefSummary': 'This is open-label, multicenter, Phase Ib study is designed to evaluate the Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in participants with advanced solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.\n2. Male or female subjects ≥18 years and ≤75 years.\n3. At least one measurable lesion per RECIST version 1.1\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1\n5. Life expectancy of ≥ 12 weeks.\n6. Adequate hematologic and end organ function\n\nExclusion Criteria:\n\n1. Failure to recover from adverse events from the most recent anti-tumor treatments\n2. Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.\n3. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs.\n4. Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer,uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.\n5. Pregnancy, lactation, breastfeeding.\n6. Previous exposure to any anti-TIGIT antibody, or recombinant protein.'}, 'identificationModule': {'nctId': 'NCT05172856', 'briefTitle': 'A Phase Ib Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Phase Ib, Open-Label, Multi-Center, Study of Primary Efficacy and Safety of IBI321 Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CIBI321A103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBI321 in advanced solid tumors', 'interventionNames': ['Drug: IBI321']}], 'interventions': [{'name': 'IBI321', 'type': 'DRUG', 'description': 'IBI321 at a dose no higher than RP2D, D1 IV Q3W.', 'armGroupLabels': ['IBI321 in advanced solid tumors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410013', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Lin Wu', 'role': 'CONTACT', 'email': 'wulin-calf@vip.163.com', 'phone': '13170419973'}], 'facility': 'Hunan Cancer Hospital', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Yang Wu', 'role': 'CONTACT', 'email': 'yang.wu@innoventbio.com', 'phone': '18117822381'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}