[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542941":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":112,"collaborators":11,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":11,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":11,"enrollmentInfo":123,"targetDuration":11,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":11,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-label: IBI3001 monotherapy","EXPERIMENTAL",null,[13],"Drug: IBI3001",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","IBI3001","The provisional dose levels are planned to be evaluated, but it is possible for additional and\u002For intermediate dose levels to be added during the study.\n\nIBI3001 is proposed to be administered by intravenous infusion (IV)",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Sujie Zhang","CONTACT","86-13811303576","sujie.zhang@innoventbio.com",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Yue Qu","86-18664524992","yue.qu@innoventbio.com",[31,49,64,82,97],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Wollongong Public","RECRUITING","Wollongong","New South Wales","2500","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],150.89345,-34.424,{"lat":43,"lon":42},[46],{"name":47,"role":23,"phone":11,"phoneExt":11,"email":48},"Daniel Brungs","Daniel.brungs@health.nsw.gov.au",{"facility":50,"status":33,"city":51,"state":52,"zip":53,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Cancer Research SA","Adelaide","South Australia","5000",{"type":40,"coordinates":55},[56,57],138.59863,-34.92866,{"lat":57,"lon":56},[60],{"name":61,"role":23,"phone":62,"phoneExt":11,"email":63},"Vineet Kwatra","61883592565","vkwatra@crsa.au",{"facility":65,"status":66,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Chinese PLA General Hospital","NOT_YET_RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":40,"coordinates":73},[74,75],116.39723,39.9075,{"lat":75,"lon":74},[78],{"name":79,"role":23,"phone":80,"phoneExt":11,"email":81},"Yi Hu","13911031189","huyi0401@aliyun.com",{"facility":83,"status":66,"city":84,"state":85,"zip":86,"country":70,"countryCode":71,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Shanghai East Hospital","Shanghai","Shanghai Municipality","200120",{"type":40,"coordinates":88},[89,90],121.45806,31.22222,{"lat":90,"lon":89},[93],{"name":94,"role":23,"phone":95,"phoneExt":11,"email":96},"Caicun Zhou","13301825532","caicunzhoudr@163.com",{"facility":98,"status":66,"city":99,"state":100,"zip":101,"country":70,"countryCode":71,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"The First Affiliated Hospital of zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":40,"coordinates":103},[104,105],120.16142,30.29365,{"lat":105,"lon":104},[108],{"name":109,"role":23,"phone":110,"phoneExt":11,"email":111},"Tingbo Liang","13666676128","liangtingbo_trial@163.com",{"type":113,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100542941","phase-1-ibi3001-in-participants-with-unresectable-locally-advanced-or-metastatic-solid-tumors-100542941",false,"NCT06349408","IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors","A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n1. Male or female participants ≥ 18 years old;\n2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;\n3. Has an anticipated life expectancy of ≥ 12 weeks;\n4. Adequate bone marrow and organ function:\n5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.\n6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.\n\nKey Exclusion Criteria:\n\n1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;\n2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;\n3. Pyloric obstruction and\u002For persistent recurrent vomiting (≥ 3 times in 24 hours);\n4. Gastrointestinal perforation and\u002For fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;\n5. Known symptomatic central nervous system (CNS) metastases.\n6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;\n7. History of endotracheal or gastrointestinal stent implantation;\n8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;\n9. Esophageal or gastric varices requiring immediate intervention;\n10. Not eligible to participate in this study at the discretion of the investigator;\n11. Do not have adequate treatment washout period before study drug administration. -","ALL","18 Years",{"count":124,"type":125},250,"ESTIMATED","INTERVENTIONAL",[128],"PHASE1","This is a Phase 1 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD\u002FRP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.",[131],"Locally Advanced Solid Tumor","2025-01-23",{"date":134,"type":135},"2025-01-27","ACTUAL",{"date":137,"type":135},"2025-01-10",{"date":139,"type":125},"2027-12-31",{"name":5,"class":6},5]