[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562596":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":51,"interventions":57,"overallOfficials":43,"centralContacts":63,"locations":69,"responsibleParty":87,"collaborators":43,"id":89,"slug":43,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":43,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":43,"studyType":101,"phases":102,"briefSummary":105,"conditions":106,"keywords":43,"overallStatus":72,"whyStopped":43,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":43},[9,13,16,20],{"measure":10,"description":11,"timeFrame":12},"Maximum tolerated dose","The Maximum tolerated dose of SHR-7787 injection monotherapy","first dose of study medication up to 21 days",{"measure":14,"description":15,"timeFrame":12},"Recommended phase II dose","The Recommended phase II dose of SHR-7787 injection monotherapy",{"measure":17,"description":18,"timeFrame":19},"Incidence and severity of adverse events (AEs)\u002Fserious adverse events (SAEs)","Incidence and severity of adverse events (AEs)\u002Fserious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0","from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks",{"measure":21,"description":22,"timeFrame":23},"Incidence of Dose Limited Toxicity (DLT)","Incidence of Dose Limited Toxicity (DLT) described in the protocol","from first dose to 4 weeks",[25,29,31,33,35,39],{"measure":26,"description":27,"timeFrame":28},"Tmax","PK parameters of single dose of SHR-7787 injection monotherapy","predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose",{"measure":30,"description":27,"timeFrame":28},"Cmax",{"measure":32,"description":27,"timeFrame":28},"AUC0-t",{"measure":34,"description":27,"timeFrame":28},"t1\u002F2",{"measure":36,"description":37,"timeFrame":38},"ADA","Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy","0.5 hour before first dose through study completion, an average of 1 year",{"measure":40,"description":41,"timeFrame":42},"ORR","Objective Response Rate, Efficacy endpoints of SHR-7787 injection monotherapy in treatment of patients with advanced solid tumors","from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":47,"primaryPurpose":48,"observationalModel":43,"timePerspective":43,"maskingInfo":49},"NA","SINGLE_GROUP","SHR-7787 injection monotherapy","TREATMENT",{"masking":50,"maskingDescription":43,"whoMasked":43},"NONE",[52],{"label":53,"type":54,"description":43,"interventionNames":55},"Single Group: SHR-7787 injection","EXPERIMENTAL",[56],"Drug: SHR-7787 injection",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":43},"DRUG","SHR-7787 injection","Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted.",[53],[64],{"name":65,"role":66,"phone":67,"phoneExt":43,"email":68},"Ke Ma","CONTACT","+0518-81220121","ke.ma@hengrui.com",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Shanghai Pulmonary Hospital","RECRUITING","Shanghai","Shanghai Municipality","200433","China","CN",{"type":79,"coordinates":80},"Point",[81,82],121.45806,31.22222,{"lat":82,"lon":81},[85],{"name":86,"role":66,"phone":43,"phoneExt":43,"email":43},"Shengxiang Ren",{"type":88,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","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":99,"type":100},201,"ESTIMATED","INTERVENTIONAL",[103,104],"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.",[107],"Advanced Solid Tumors","2024-10-17",{"date":110,"type":111},"2024-10-18","ACTUAL",{"date":113,"type":111},"2024-10-04",{"date":115,"type":100},"2026-11-30",{"name":5,"class":6},1]