[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548212":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":53,"collaborators":11,"id":55,"slug":11,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":11,"enrollmentInfo":63,"targetDuration":11,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IBI3005","EXPERIMENTAL",null,[13],"Drug: IBI3005",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \\& D code: IBI3005)",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Yanxi Pu","CONTACT","18523197816","yanxi.pu@innoventbio.com",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Shandong Cancer Hospital & Institute","RECRUITING","Jinan","Shandong","250117","China",{"type":34,"coordinates":35},"Point",[36,37],116.99722,36.66833,{"lat":37,"lon":36},[40,44,48,51],{"name":41,"role":22,"phone":42,"phoneExt":11,"email":43},"Jinming Yu","13806406293","sdyujinming@126.com",{"name":45,"role":22,"phone":46,"phoneExt":11,"email":47},"Yuping Sun","13370582181","13370582181@126.com",{"name":49,"role":50,"phone":11,"phoneExt":11,"email":11},"Jinming Yu, M.D.","PRINCIPAL_INVESTIGATOR",{"name":52,"role":50,"phone":11,"phoneExt":11,"email":11},"Yuping Sun, M.D.",{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100548212",false,"NCT06418061","Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors","A Multicenter, Open-label, Phase Ia\u002FIb Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI3005 in Subjects With Advanced Malignant Solid Tumors","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\u002F2 Ab positive);\n* Acute or chronic active hepatitis B (HbsAg positive and\u002For HbcAb positive with HBV DNA titer ≥ 104 copies\u002FmL or ≥ 2000 IU\u002FmL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer \\> 103 copies\u002FmL 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\u002Fshort 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;","ALL","18 Years",{"count":64,"type":65},198,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","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.",[71,72],"Unresectable","Locally Advanced or Metastatic Solid Tumors","2025-01-19",{"date":75,"type":76},"2025-01-22","ACTUAL",{"date":78,"type":76},"2025-01-08",{"date":80,"type":65},"2027-12-31",{"name":5,"class":6},1]