Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-01-09 @ 3:05 PM
Study NCT ID:
NCT06418061
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 198}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-19', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-13', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numbers of subjects with adverse events', 'timeFrame': 'Up to 3 years', 'description': 'defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed'}, {'measure': 'Number of subjects with clinically significant changes in physical examination results', 'timeFrame': 'Up to 3 years', 'description': 'Clinically significant abnormal physical examination findings reported by the investigator.'}, {'measure': 'Number of subjects with clinically significant changes in vital signs', 'timeFrame': 'Up to 3 years', 'description': 'Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure'}, {'measure': 'Dose limiting toxicities (DLTs)', 'timeFrame': 'Up to 4 weeks', 'description': 'Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.'}], 'secondaryOutcomes': [{'measure': 'area under the curve (AUC)', 'timeFrame': 'up to 3 years', 'description': 'area under the curve (AUC) of single and multiple doses of IBI3005'}, {'measure': 'maximum concentration (Cmax)', 'timeFrame': 'up to 3 years', 'description': 'maximum concentration (Cmax) of single and multiple doses of IBI3005'}, {'measure': 'time to maximum concentration (Tmax)', 'timeFrame': 'up to 3 years', 'description': 'time to maximum concentration (Tmax) of single and multiple doses of IBI3005'}, {'measure': 'clearance (CL)', 'timeFrame': 'up to 3 years', 'description': 'clearance (CL) of single and multiple doses of IBI3005'}, {'measure': 'apparent volume of distribution (V)', 'timeFrame': 'up to 3 years', 'description': 'apparent volume of distribution (V) of single and multiple doses of IBI3005'}, {'measure': 'half-life (t1/2)', 'timeFrame': 'up to 3 years', 'description': 'half-life (t1/2) of IBI3005 to the last administration of IBI3005'}, {'measure': 'anti-drug antibody (ADA)', 'timeFrame': 'up to 3 years', 'description': 'Incidence and characterization of anti-drug antibody (ADA).'}, {'measure': 'objective response rate (ORR)', 'timeFrame': 'up to 3 years', 'description': 'objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.'}, {'measure': 'duration of response (DoR)', 'timeFrame': 'up to 3 years', 'description': 'duration of response (DoR) as evaluated per the RECIST v1.1 criteria.'}, {'measure': 'time to response (TTR)', 'timeFrame': 'up to 3 years', 'description': 'time to response (TTR) as evaluated per the RECIST v1.1 criteria.'}, {'measure': 'progression free survival (PFS)', 'timeFrame': 'up to 3 years', 'description': 'as evaluated per the RECIST v1.1 criteria.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unresectable', 'Locally Advanced or Metastatic Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.\n\nExclusion Criteria:\n\nReceived live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.\n\nUncontrolled diseases including:\n\n* Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug（ antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed）;\n* Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);\n* Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer ≥ 104 copies/mL or ≥ 2000 IU/mL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer \\> 103 copies/mL or higher than lower limit of detection);\n* Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;\n* Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;\n* Active syphilis infection or latent syphilis requiring treatment;\n* Symptomatic congestive heart failure Grade II-IV (New York Heart Association \\[NYHA\\]), symptomatic or uncontrolled arrhythmias, QTc interval \\> 480 ms or personal or family history of congenital long/short QT syndrome;\n* Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;'}, 'identificationModule': {'nctId': 'NCT06418061', 'briefTitle': 'Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI3005 in Subjects With Advanced Malignant Solid Tumors', 'orgStudyIdInfo': {'id': 'CIBI3005A101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IBI3005', 'interventionNames': ['Drug: IBI3005']}], 'interventions': [{'name': 'IBI3005', 'type': 'DRUG', 'description': 'Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \\& D code: IBI3005)', 'armGroupLabels': ['IBI3005']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jinming Yu', 'role': 'CONTACT', 'email': 'sdyujinming@126.com', 'phone': '13806406293'}, {'name': 'Yuping Sun', 'role': 'CONTACT', 'email': '13370582181@126.com', 'phone': '13370582181'}, {'name': 'Jinming Yu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuping Sun, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shandong Cancer Hospital & Institute', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yanxi Pu', 'role': 'CONTACT', 'email': 'yanxi.pu@innoventbio.com', 'phone': '18523197816'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}