[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610717":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":40,"centralContacts":41,"locations":50,"responsibleParty":72,"collaborators":40,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":40,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":40,"studyType":87,"phases":88,"briefSummary":91,"conditions":92,"keywords":40,"overallStatus":53,"whyStopped":40,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Shanghai Shengdi Pharmaceutical Co., Ltd","INDUSTRY",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 Group","EXPERIMENTAL","SHR-4610 dose A in dose escalation stage.",[13],"Drug: SHR-4610 Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2 Group","SHR-4610 dose B in dose escalation stage.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3 Group","SHR-4610 dose C in dose escalation stage.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4 Group","SHR-4610 dose D in dose escalation stage.",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Cohort 5 Group","SHR-4610 dose A\u002FB\u002FC\u002FD in dose expansion stage.",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Cohort 6 Group","SHR-4610 dose A\u002FB\u002FC\u002FD in efficacy expansion stage.",[13],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","SHR-4610 Injection","SHR-4610 injection in different dose.",[9,15,19,23,27,31],null,[42,47],{"name":43,"role":44,"phone":45,"phoneExt":40,"email":46},"Yunpeng Jin","CONTACT","+86-021-61053363","yunpeng.jin.yj1@hengrui.com",{"name":48,"role":44,"phone":45,"phoneExt":40,"email":49},"Yuting Wang","yuting.wang@hengrui.com",[51],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Zhejiang Cancer Hospital","RECRUITING","Hangzhou","Zhejiang","310022","China","CN",{"type":60,"coordinates":61},"Point",[62,63],120.16142,30.29365,{"lat":63,"lon":62},[66,70],{"name":67,"role":44,"phone":68,"phoneExt":40,"email":69},"Xiangdong Cheng","+86-0571-88888888","Chengxd1316@126.com",{"name":67,"role":71,"phone":40,"phoneExt":40,"email":40},"PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100610717","phase-1-a-study-of-shr-4610-injection-in-patients-with-advanced-solid-tumors-100610717",false,"NCT07231211","A Study of SHR-4610 Injection in Patients With Advanced Solid Tumors","An Open-label, Multicenter Phase I\u002FII Clinical Study of SHR-4610 Injection in Patients With Advanced Solid Tumors to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy","Inclusion Criteria:\n\n1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;\n2. Age range: 18-75 years old, both male and female are welcome;\n3. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment;\n4. Have at least one measurable tumor lesion per RECIST v1.1;\n5. ECOG performance status of 0-1;\n6. Life expectancy ≥ 12 weeks;\n7. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Patients with active central nervous system metastases or meningeal metastases;\n2. Systemic antitumor therapy was received 4 weeks before the start of the study;\n3. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion;\n4. Have poorly controlled or severe cardiovascular disease;\n5. Subjects with active hepatitis B or active hepatitis C;\n6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.","ALL","18 Years","75 Years",{"count":85,"type":86},258,"ESTIMATED","INTERVENTIONAL",[89,90],"PHASE1","PHASE2","This study is an open, multicenter Phase I\u002FII clinical trial, divided into two stages: dose exploration (including dose escalation and dose extension) and efficacy extension.",[93],"Solid Tumors","2026-01-07",{"date":96,"type":97},"2026-01-09","ACTUAL",{"date":99,"type":97},"2025-11-20",{"date":101,"type":86},"2027-12",{"name":5,"class":6},1]