[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610717":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":11,"studyPopulation":11,"armGroups":47,"interventions":74,"overallOfficials":11,"centralContacts":80,"locations":89,"responsibleParty":111,"collaborators":11,"id":113,"slug":11,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":11,"eligibilityCriteria":118,"healthyVolunteers":114,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":11,"studyType":125,"phases":126,"briefSummary":129,"conditions":130,"keywords":11,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Shanghai Shengdi Pharmaceutical Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":11},[9,13,15,17],{"measure":10,"description":11,"timeFrame":12},"The Dose-Limiting Toxicity (DLT)",null,"Post-dose at day 1 to the end of treatment visit, about 1 year.",{"measure":14,"description":11,"timeFrame":12},"The Maximum Tolerated Dose (MTD)",{"measure":16,"description":11,"timeFrame":12},"Recommended dosage for Phase II (RP2D)",{"measure":18,"description":11,"timeFrame":19},"Incidence and severity of adverse events (AEs)","Up to 90 days after the last administration.",[21,24,26,28,30,32,35,37,39],{"measure":22,"description":11,"timeFrame":23},"Objective Response Rate (ORR)","From the first administration to the end of treatment visit, about 1 year.",{"measure":25,"description":11,"timeFrame":23},"Duration of relief (DOR)",{"measure":27,"description":11,"timeFrame":23},"Disease Control Rate (DCR)",{"measure":29,"description":11,"timeFrame":23},"Time to Response (TTR)",{"measure":31,"description":11,"timeFrame":23},"Progression-free survival (PFS)",{"measure":33,"description":11,"timeFrame":34},"Time to the maximum plasma concentration (Tmax)","From Day 1 pre-dose to 30 days after the last administration.",{"measure":36,"description":11,"timeFrame":34},"Maximum concentration of SHR-4610 (Cmax)",{"measure":38,"description":11,"timeFrame":34},"SHR-4610 serum trough concentration (Ctrough)",{"measure":40,"description":11,"timeFrame":34},"Area under the concentration versus time curve of SHR-4610 from time zero to time t (AUC0-t)",{"allocation":42,"interventionModel":43,"interventionModelDescription":11,"primaryPurpose":44,"observationalModel":11,"timePerspective":11,"maskingInfo":45},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":46,"maskingDescription":11,"whoMasked":11},"NONE",[48,54,58,62,66,70],{"label":49,"type":50,"description":51,"interventionNames":52},"Cohort 1 Group","EXPERIMENTAL","SHR-4610 dose A in dose escalation stage.",[53],"Drug: SHR-4610 Injection",{"label":55,"type":50,"description":56,"interventionNames":57},"Cohort 2 Group","SHR-4610 dose B in dose escalation stage.",[53],{"label":59,"type":50,"description":60,"interventionNames":61},"Cohort 3 Group","SHR-4610 dose C in dose escalation stage.",[53],{"label":63,"type":50,"description":64,"interventionNames":65},"Cohort 4 Group","SHR-4610 dose D in dose escalation stage.",[53],{"label":67,"type":50,"description":68,"interventionNames":69},"Cohort 5 Group","SHR-4610 dose A\u002FB\u002FC\u002FD in dose expansion stage.",[53],{"label":71,"type":50,"description":72,"interventionNames":73},"Cohort 6 Group","SHR-4610 dose A\u002FB\u002FC\u002FD in efficacy expansion stage.",[53],[75],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":11},"DRUG","SHR-4610 Injection","SHR-4610 injection in different dose.",[49,55,59,63,67,71],[81,86],{"name":82,"role":83,"phone":84,"phoneExt":11,"email":85},"Yunpeng Jin","CONTACT","+86-021-61053363","yunpeng.jin.yj1@hengrui.com",{"name":87,"role":83,"phone":84,"phoneExt":11,"email":88},"Yuting Wang","yuting.wang@hengrui.com",[90],{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":104},"Zhejiang Cancer Hospital","RECRUITING","Hangzhou","Zhejiang","310022","China","CN",{"type":99,"coordinates":100},"Point",[101,102],120.16142,30.29365,{"lat":102,"lon":101},[105,109],{"name":106,"role":83,"phone":107,"phoneExt":11,"email":108},"Xiangdong Cheng","+86-0571-88888888","Chengxd1316@126.com",{"name":106,"role":110,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":112,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":123,"type":124},258,"ESTIMATED","INTERVENTIONAL",[127,128],"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.",[131],"Solid Tumors","2026-01-07",{"date":134,"type":135},"2026-01-09","ACTUAL",{"date":137,"type":135},"2025-11-20",{"date":139,"type":124},"2027-12",{"name":5,"class":6},1]