[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652076":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":29,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":70,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Beijing Suncadia Pharmaceuticals Co., Ltd","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SHR-8203 Injection","EXPERIMENTAL",null,[13],"Drug: SHR-8203 Injection",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","SHR-8203 Injection Dose 1\u002F Dose 2\u002F Dose 3\u002F Dose 4",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Fang fang Peng, Doctoral degree","CONTACT","17721288185","fangfang.peng.fp5@hengrui.com",{"name":26,"role":22,"phone":27,"phoneExt":11,"email":28},"Xin Xu, Bachelor's degree","18036618833","xin.xu@hengrui.com",[30],{"facility":31,"status":11,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Shanghai East Hospital","Shanghai","Shanghai Municipality","200433","China","CN",{"type":38,"coordinates":39},"Point",[40,41],121.45806,31.22222,{"lat":41,"lon":40},[44],{"name":45,"role":22,"phone":46,"phoneExt":11,"email":47},"Caicun Zhou","021-58822171","caicunzhoudr@163.com",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100652076","phase-1-phase-iii-clinical-trials-of-shr-8203-injection-in-participants-with-advanced-solid-tumors-100652076",false,"NCT07769242","Phase I\u002FII Clinical Trials of SHR-8203 Injection in Participants With Advanced Solid Tumors","An Open-label, Multi-center Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-8203 Injection in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Age between 18 and 75 years old, gender not limited;\n2. Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.\n3. Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment;\n4. Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.\n5. Have at least one measurable lesion as per RECIST v1.1;\n6. ECOG PS score: 0-1;\n7. Good organ function level.\n\nExclusion Criteria:\n\n1. Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage;\n2. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;\n3. Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;\n4. Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;\n5. Participants who have experienced severe infections within one month prior to the first medication.","ALL","18 Years","75 Years",{"count":61,"type":62},200,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","This trial is a multicenter, open-label Phase I\u002FII clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.",[69],"Solid Tumors","NOT_YET_RECRUITING","2026-08-12",{"date":73,"type":74},"2026-08-17","ACTUAL",{"date":76,"type":62},"2026-09-01",{"date":78,"type":62},"2029-12-30",{"name":5,"class":6},1]