[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537734":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":204,"collaborators":19,"id":206,"slug":207,"hasResults":208,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":19,"eligibilityCriteria":212,"healthyVolunteers":208,"sex":213,"minAge":214,"maxAge":19,"enrollmentInfo":215,"targetDuration":19,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":19,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IBI363","EXPERIMENTAL","IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks.",[13],"Drug: IBI363",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","IBI363 will be administered as an intravenous (IV) infusion every 2 weeks or every 3 weeks. Subjects will receive study medication until disease progression, toxicity intolerance, withdrawal of consent, the duration of treatment reaches 24 months, or any other reason that requires discontinuation of the study treatment, whichever occurs first.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Amanda Guo","CONTACT","1-832-207-5244","amanda.guo@innoventbio.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"William Liu","1-917-436-6817","william.liu01@innoventbio.com",[31,55,74,93,113,133,149,169,184],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University of California, San Francisco (UCSF)","RECRUITING","San Francisco","California","94143","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-122.41942,37.77493,{"lat":43,"lon":42},[46,50,54],{"name":47,"role":23,"phone":48,"phoneExt":19,"email":49},"Katy Tsai, MD","415-353-9900","Katy.Tsai@ucsf.edu",{"name":51,"role":23,"phone":52,"phoneExt":19,"email":53},"Michael Wong","415-502-5483","Michael.Wong2@ucsf.edu",{"name":47,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":56,"status":33,"city":57,"state":58,"zip":59,"country":37,"countryCode":38,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Ocala Oncology Center","Ocala","Florida","34474",{"type":40,"coordinates":61},[62,63],-82.14009,29.1872,{"lat":63,"lon":62},[66,70,73],{"name":67,"role":23,"phone":68,"phoneExt":19,"email":69},"Ketan Doshi, MD","352-547-1958","Ketan.Doshi@USONCOLOGY.COM",{"name":71,"role":23,"phone":68,"phoneExt":19,"email":72},"Sanjit Nirmalanandhan, Ph.D.","Sanjit.Nirmalanandhan@usoncology.com",{"name":67,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":75,"status":33,"city":76,"state":58,"zip":77,"country":37,"countryCode":38,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"BRCR Medical Center","Plantation","33322",{"type":40,"coordinates":79},[80,81],-80.23184,26.13421,{"lat":81,"lon":80},[84,88,92],{"name":85,"role":23,"phone":86,"phoneExt":19,"email":87},"Chintan Gandhi, MD","561-447-0614","Cghandhi.md@brcrglobal.com",{"name":89,"role":23,"phone":86,"phoneExt":90,"email":91},"Diana Casaa","142","dianac@brcrglobal.com",{"name":85,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":94,"status":33,"city":95,"state":96,"zip":97,"country":37,"countryCode":38,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"University of Kansas Medical Center (KUMC)","Fairway","Kansas","66205",{"type":40,"coordinates":99},[100,101],-94.6319,39.02223,{"lat":101,"lon":100},[104,108,112],{"name":105,"role":23,"phone":106,"phoneExt":19,"email":107},"Saqib Abbasi, MD","913-945-7545","sabbasi@kumc.edu",{"name":109,"role":23,"phone":110,"phoneExt":19,"email":111},"Laura Mitchell","(913) 574-2854","lmitchell11@kumc.edu",{"name":105,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":114,"status":33,"city":115,"state":116,"zip":117,"country":37,"countryCode":38,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Michigan Hematology & Oncology Consultants - MedOnc Dearborn","Dearborn","Michigan","48126",{"type":40,"coordinates":119},[120,121],-83.17631,42.32226,{"lat":121,"lon":120},[124,128,132],{"name":125,"role":23,"phone":126,"phoneExt":19,"email":127},"Faisal Musa, MD","313-514-4200","Fmusa@mhpdoctor.com",{"name":129,"role":23,"phone":130,"phoneExt":19,"email":131},"Heather Austin","585-216-7617","heather.austin@profoundresearch.io",{"name":125,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":134,"status":33,"city":135,"state":116,"zip":136,"country":37,"countryCode":38,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Michigan Hematology & Oncology Consultants - MedOnc Troy","Troy","48098",{"type":40,"coordinates":138},[139,140],-83.14993,42.60559,{"lat":140,"lon":139},[143,147,148],{"name":144,"role":23,"phone":145,"phoneExt":19,"email":146},"Laura Nadeau, MD","206-667-4763","lnadeau@mhpdoctor.com",{"name":129,"role":23,"phone":130,"phoneExt":19,"email":131},{"name":144,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":150,"status":33,"city":151,"state":152,"zip":153,"country":37,"countryCode":38,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"MD Anderson Cancer Center-University of Texas","Houston","Texas","77025",{"type":40,"coordinates":155},[156,157],-95.36327,29.76328,{"lat":157,"lon":156},[160,164,168],{"name":161,"role":23,"phone":162,"phoneExt":19,"email":163},"Sarina Piha-Paul, MD","713-563-1055","spihapau@mdanderson.org",{"name":165,"role":23,"phone":166,"phoneExt":19,"email":167},"Qian Peng","713- 416-9928","qpeng@mdanderson.org",{"name":161,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":170,"status":33,"city":151,"state":152,"zip":171,"country":37,"countryCode":38,"cosmosGeoPoint":172,"geoPoint":174,"contacts":175},"Oncology Consultants P.A.","77030",{"type":40,"coordinates":173},[156,157],{"lat":157,"lon":156},[176,180],{"name":177,"role":23,"phone":178,"phoneExt":19,"email":179},"Mahran Shoukier","1-713-600-0913","mshoukier@oncologyconsu.com",{"name":181,"role":23,"phone":178,"phoneExt":182,"email":183},"Bryand Osorio","1008","bosorio@oncologyconsultants.com",{"facility":185,"status":33,"city":186,"state":187,"zip":188,"country":37,"countryCode":38,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":40,"coordinates":190},[191,192],-122.33207,47.60621,{"lat":192,"lon":191},[195,199,203],{"name":196,"role":23,"phone":197,"phoneExt":19,"email":198},"Diane Tseng, MD","206-606-2936","ditseng@uw.edu",{"name":200,"role":23,"phone":201,"phoneExt":19,"email":202},"Margaret Busey","206-667-2388","mbusey2@fredhutch.org",{"name":196,"role":23,"phone":19,"phoneExt":19,"email":19},{"type":205,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100537734","phase-2-a-study-of-ibi363-in-subjects-with-advanced-solid-malignancies-100537734",false,"NCT06281678","A Study of IBI363 in Subjects with Advanced Solid Malignancies","A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies","Inclusion Criteria:\n\n1. Subjects 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 subjects ≥ 18 years old;\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;\n4. Anticipated life expectancy of ≥ 3 months;\n\nExclusion Criteria:\n\n1. Inadequate bone marrow and organ function;\n2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose\n3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;\n4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;\n5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.","ALL","18 Years",{"count":216,"type":217},178,"ESTIMATED","INTERVENTIONAL",[220],"PHASE2","This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.",[223,224,225,226],"Melanoma","Non-small Cell Lung Cancer","Colorectal Cancer","Renal Cell Cancer","2024-12-16",{"date":229,"type":230},"2024-12-19","ACTUAL",{"date":232,"type":230},"2024-04-08",{"date":234,"type":217},"2026-12-31",{"name":5,"class":6},9]