[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590120":3},{"organization":4,"outcomesModule":7,"designInfo":72,"detailedDescription":71,"studyPopulation":71,"armGroups":78,"interventions":84,"overallOfficials":71,"centralContacts":89,"locations":95,"responsibleParty":230,"collaborators":232,"id":235,"slug":71,"hasResults":236,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":71,"eligibilityCriteria":240,"healthyVolunteers":236,"sex":241,"minAge":242,"maxAge":243,"enrollmentInfo":244,"targetDuration":71,"studyType":247,"phases":248,"briefSummary":250,"conditions":251,"keywords":71,"overallStatus":98,"whyStopped":71,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},{"fullName":5,"class":6},"Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":32,"otherOutcomes":71},[9,13,16,19,22,26,29],{"measure":10,"description":11,"timeFrame":12},"Numbers of subjects with adverse events","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","Up to 3 years",{"measure":14,"description":15,"timeFrame":12},"Number of subjects with clinically significant changes in physical examination results","Clinically significant abnormal physical examination findings reported by the investigator.",{"measure":17,"description":18,"timeFrame":12},"Number of subjects with clinically significant changes in electrocardiogram","Clinically significant abnormal electrocardiogram findings reported by the investigator.",{"measure":20,"description":21,"timeFrame":12},"Number of subjects with clinically significant changes in vital signs","Vital signs including body temperature, pulse, respiratory rate, oxygen saturation by pulse oximetry at rest and blood pressure",{"measure":23,"description":24,"timeFrame":25},"Dose limiting toxicities (DLTs)","Dose limiting toxicities (DLTs) to establish MTD and\u002For RP2D.","Up to 21 days",{"measure":27,"description":28,"timeFrame":12},"objective response rate (ORR)","objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.",{"measure":30,"description":31,"timeFrame":12},"Number of subjects with clinically significant changes in laboratory parameters","Clinically significant abnormal laboratory parameters findings reported by the investigator.",[33,36,39,42,45,48,51,54,55,58,61,64,67],{"measure":34,"description":35,"timeFrame":12},"area under the curve (AUC)","area under the curve (AUC) of single and multiple doses of IBI3020",{"measure":37,"description":38,"timeFrame":12},"maximum concentration (Cmax)","maximum concentration (Cmax) of single and multiple doses of IBI3020",{"measure":40,"description":41,"timeFrame":12},"time to maximum concentration (Tmax)","time to maximum concentration (Tmax) of single and multiple doses of IBI3020",{"measure":43,"description":44,"timeFrame":12},"clearance (CL)","clearance (CL) of single and multiple doses of IBI3020",{"measure":46,"description":47,"timeFrame":12},"apparent volume of distribution (V)","apparent volume of distribution (V) of single and multiple doses of IBI3020",{"measure":49,"description":50,"timeFrame":12},"half-life (t1\u002F2)","half-life (t1\u002F2) of IBI3020 to the last administration of IBI3020",{"measure":52,"description":53,"timeFrame":12},"anti-drug antibody (ADA)","Incidence and characterization of anti-drug antibody (ADA).",{"measure":27,"description":28,"timeFrame":12},{"measure":56,"description":57,"timeFrame":12},"duration of response (DoR)","duration of response (DoR) as evaluated per the RECIST v1.1 criteria.",{"measure":59,"description":60,"timeFrame":12},"time to response (TTR)","time to response (TTR) as evaluated per the RECIST v1.1 criteria.",{"measure":62,"description":63,"timeFrame":12},"progression free survival (PFS)","as evaluated per the RECIST v1.1 criteria.",{"measure":65,"description":66,"timeFrame":12},"disease control rate (DCR)","disease control rate (DCR)as evaluated per the RECIST v1.1 criteria.",{"measure":68,"description":69,"timeFrame":70},"overall survival (OS)","OS is defined as the time from the date of first dose of study drug until the date of death from any cause.","From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months",null,{"allocation":73,"interventionModel":74,"interventionModelDescription":71,"primaryPurpose":75,"observationalModel":71,"timePerspective":71,"maskingInfo":76},"NA","SEQUENTIAL","TREATMENT",{"masking":77,"maskingDescription":71,"whoMasked":71},"NONE",[79],{"label":80,"type":81,"description":71,"interventionNames":82},"IBI3020","EXPERIMENTAL",[83],"Drug: IBI3020",[85],{"type":86,"name":80,"description":87,"armGroupLabels":88,"otherNames":71},"DRUG","Recombinant anti-CEACAM5 monoclonal antibody - dual-payload conjugate for injection",[80],[90],{"name":91,"role":92,"phone":93,"phoneExt":71,"email":94},"Serena Dong","CONTACT","051269566088","suhua.dong@innoventbio.com",[96,109,125,140,154,169,183,199,216],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":71,"geoPoint":71,"contacts":104},"Mayo Clinic - Arizona","RECRUITING","Pheonix","Arizona","85054","United States","US",[105],{"name":106,"role":92,"phone":107,"phoneExt":71,"email":108},"Mitesh Borad, Dr","480-301-8000","Borad.Mitesh@mayo.edu",{"facility":110,"status":98,"city":111,"state":112,"zip":113,"country":102,"countryCode":103,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"Mayo Clinic - Florida","Jacksonville","Florida","32224",{"type":115,"coordinates":116},"Point",[117,118],-81.65565,30.33218,{"lat":118,"lon":117},[121],{"name":122,"role":92,"phone":123,"phoneExt":71,"email":124},"Yanyan Lou, Dr.","(480) 342-2000","Lou.Yanyan@mayo.edu",{"facility":126,"status":98,"city":127,"state":128,"zip":129,"country":102,"countryCode":103,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Mayo Clinic - Rochester","Rochester","Minnesota","55905",{"type":115,"coordinates":131},[132,133],-92.4699,44.02163,{"lat":133,"lon":132},[136],{"name":137,"role":92,"phone":138,"phoneExt":71,"email":139},"Hao Xie, Dr","(507) 512-1667","Xie.Hao@mayo.edu",{"facility":141,"status":98,"city":142,"state":142,"zip":143,"country":102,"countryCode":103,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Montefiore Cancer Center","New York","10461",{"type":115,"coordinates":145},[146,147],-74.00597,40.71427,{"lat":147,"lon":146},[150],{"name":151,"role":92,"phone":152,"phoneExt":71,"email":153},"Fernand Bteich, Dr.","(718) 405-8124","fbteich@montefiore.org",{"facility":155,"status":98,"city":156,"state":157,"zip":158,"country":102,"countryCode":103,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"NEXT Houston","Houston","Texas","77054",{"type":115,"coordinates":160},[161,162],-95.36327,29.76328,{"lat":162,"lon":161},[165],{"name":166,"role":92,"phone":167,"phoneExt":71,"email":168},"Jennifer Segar","832-384-7900","jsegar@nextoncology.com",{"facility":170,"status":98,"city":171,"state":157,"zip":172,"country":102,"countryCode":103,"cosmosGeoPoint":173,"geoPoint":177,"contacts":178},"NEXT Dallas","Irving","75039",{"type":115,"coordinates":174},[175,176],-96.94889,32.81402,{"lat":176,"lon":175},[179],{"name":180,"role":92,"phone":181,"phoneExt":71,"email":182},"Shiraj Sen","972-893-8800","ssen@nextoncology.com",{"facility":184,"status":98,"city":185,"state":186,"zip":71,"country":187,"countryCode":188,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"The sixth affiliated hospital, Sun Yat-sen University","Guangzhou","Guangdong","China","CN",{"type":115,"coordinates":190},[191,192],113.25,23.11667,{"lat":192,"lon":191},[195],{"name":196,"role":92,"phone":197,"phoneExt":71,"email":198},"Yanhong Deng","020-38254000","13925106525@163.com",{"facility":200,"status":98,"city":201,"state":202,"zip":71,"country":187,"countryCode":188,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Shandong Cancer Hospital","Jinan","Shandong",{"type":115,"coordinates":204},[205,206],116.99722,36.66833,{"lat":206,"lon":205},[209,213],{"name":210,"role":92,"phone":211,"phoneExt":71,"email":212},"Jinming Yu","0531-87984777","sdyujinming@126.com",{"name":214,"role":92,"phone":211,"phoneExt":71,"email":215},"Yuping Sun","13370582181@163.com",{"facility":217,"status":98,"city":218,"state":219,"zip":71,"country":187,"countryCode":188,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"Shanxi Cancer Hospital","Taiyuan","Shanxi",{"type":115,"coordinates":221},[222,223],112.56028,37.86944,{"lat":223,"lon":222},[226],{"name":227,"role":92,"phone":228,"phoneExt":71,"email":229},"Jie Wang","0351-4881611","zlhuxi@163.com",{"type":231,"investigatorFullName":71,"investigatorTitle":71,"investigatorAffiliation":71,"oldNameTitle":71,"oldOrganization":71},"SPONSOR",[233],{"name":234,"class":6},"Fortvita Biologics (USA)Inc.","100590120",false,"NCT06963281","Study of IBI3020 Treatment in Participants With Late-Stage Solid Tumors","A Phase 1, Multicenter, Open-label Study of IBI3020 Treatment in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\nParticipants must satisfy all of the following criteria to be enrolled into the study:\n\n1. Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;\n2. Male or female participants ≥ 18 years old. For Part 1, age ≥ 18 years and ≤ 75 years;\n3. Histologically or cytologically confirmed unresectable, locally advanced or metastatic solid tumors which have received available standard therapies and have disease progression, or unacceptable toxic effects, or contraindications;\n4. At least 1 measurable lesion as defined per RECIST v1.1 within 28 days prior to the first dose of IBI3020;\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;\n6. Minimum life expectancy of 12 weeks;\n7. Adequate bone marrow and organ function confirmed at screening period;\n8. Participants, both male and female, who are not of childbearing potential or who agree to use at least 1 highly effective method of contraception during the study.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Previous treatment with CEACAM5-targeted therapy;\n2. Prior anti-cancer therapy within the wash-out period;\n3. Received live vaccines within 4 weeks or cancer vaccine within 3 months;\n4. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within 2 weeks or 5 half-lives;\n5. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0;\n6. Known allergies, hypersensitivity, or intolerance to IBI3020 or its excipients;\n7. Undergone major surgery within 4 weeks, or who have severe unhealed wounds;\n8. Known symptomatic central nervous system (CNS) metastases;\n9. Uncontrolled diseases or conditions;\n10. History of pneumonitis requiring corticosteroids therapy, or history of clinically significant lung diseases;\n11. History of thromboembolic event within 6 months;\n12. Under neurological, psychiatric or social condition;\n13. Women who are pregnant, have positive results in pregnancy test or are lactating;\n14. Not eligible to participate in this study at the discretion of the investigator;\n15. Participating in any other interventional clinical research.","ALL","18 Years","75 Years",{"count":245,"type":246},285,"ESTIMATED","INTERVENTIONAL",[249],"PHASE1","The main purpose of this study is to evaluate the safety and tolerability of IBI3020 and to determine the maximum tolerated dose (MTD) and\u002For the recommended dose for expansion (RP2D) of IBI3020.",[252],"Solid Tumors","2025-06-03",{"date":255,"type":256},"2025-06-06","ACTUAL",{"date":258,"type":256},"2025-04-29",{"date":260,"type":246},"2028-03-31",{"name":5,"class":6},9]