[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562596":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Group: SHR-7787 injection","EXPERIMENTAL",null,[13],"Drug: SHR-7787 injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","SHR-7787 injection","Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Ke Ma","CONTACT","+0518-81220121","ke.ma@hengrui.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Shanghai Pulmonary Hospital","RECRUITING","Shanghai","Shanghai Municipality","200433","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":11,"phoneExt":11,"email":11},"Shengxiang Ren",{"type":45,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100562596","phase-1-a-trial-of-shr-7787-injection-in-patients-with-advanced-solid-tumors-100562596",false,"NCT06605222","A Trial of SHR-7787 Injection in Patients With Advanced Solid Tumors","A Phase I\u002FII, Open Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-7787 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;\n2. Patients with unresectable recurrent or metastatic solid tumors;\n3. There is at least one lesion could be measured;\n4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;\n5. Adequate organ functions as defined;\n6. Life expectancy ≥3 months.\n\nExclusion Criteria:\n\n1. Patients with known active central nervous system (CNS) metastases;\n2. Subjects who had other malignancy in five years before the first dose;\n3. Patients with tumor-related pain that cannot be controlled as determined;\n4. Patients with serious cardiovascular and cerebrovascular diseases;\n5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;\n6. Patients with Severe infections;\n7. History of immunodeficiency;\n8. History of autoimmune diseases;\n9. Unresolved CTCAE Grade \\>1 toxicity attributed to any prior anti-tumor therapy\n10. Active infection;\n11. Pregnant or nursing women;\n12. Known history of serious allergic reactions to the investigational product or its main ingredients.","ALL","18 Years","75 Years",{"count":57,"type":58},201,"ESTIMATED","INTERVENTIONAL",[61,62],"PHASE1","PHASE2","The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.",[65],"Advanced Solid Tumors","2024-10-17",{"date":68,"type":69},"2024-10-18","ACTUAL",{"date":71,"type":69},"2024-10-04",{"date":73,"type":58},"2026-11-30",{"name":5,"class":6},1]