[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548212":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"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,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Shandong Cancer Hospital & Institute","RECRUITING","Jinan","Shandong","250117","China","CN",{"type":35,"coordinates":36},"Point",[37,38],116.99722,36.66833,{"lat":38,"lon":37},[41,45,49,52],{"name":42,"role":22,"phone":43,"phoneExt":11,"email":44},"Jinming Yu","13806406293","sdyujinming@126.com",{"name":46,"role":22,"phone":47,"phoneExt":11,"email":48},"Yuping Sun","13370582181","13370582181@126.com",{"name":50,"role":51,"phone":11,"phoneExt":11,"email":11},"Jinming Yu, M.D.","PRINCIPAL_INVESTIGATOR",{"name":53,"role":51,"phone":11,"phoneExt":11,"email":11},"Yuping Sun, M.D.",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100548212","phase-1-study-of-ibi3005-in-subjects-with-unresectable-locally-advanced-or-metastatic-solid-tumors-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":66,"type":67},198,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73,74],"Unresectable","Locally Advanced or Metastatic Solid Tumors","2025-01-19",{"date":77,"type":78},"2025-01-22","ACTUAL",{"date":80,"type":78},"2025-01-08",{"date":82,"type":67},"2027-12-31",{"name":5,"class":6},1]