[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595865":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":36,"studyPopulation":23,"armGroups":37,"interventions":82,"overallOfficials":23,"centralContacts":88,"locations":94,"responsibleParty":112,"collaborators":114,"id":118,"slug":23,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":23,"eligibilityCriteria":123,"healthyVolunteers":119,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":23,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":23,"overallStatus":97,"whyStopped":23,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Shenyang Sunshine Pharmaceutical Co., LTD.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Dose Limiting Toxicity (DLT)","DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment.","During the first cycle. Each cycle is 21 days",{"measure":14,"description":15,"timeFrame":12},"Maximum tolerated dose (MTD)","MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.",[17,21,24,26,28],{"measure":18,"description":19,"timeFrame":20},"Objective Response Rate (ORR)","Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.","Up to 2 years",{"measure":22,"description":23,"timeFrame":20},"Cmax",null,{"measure":25,"description":23,"timeFrame":20},"Tmax",{"measure":27,"description":23,"timeFrame":20},"T1\u002F2",{"measure":29,"description":23,"timeFrame":20},"AUC",{"allocation":31,"interventionModel":32,"interventionModelDescription":23,"primaryPurpose":33,"observationalModel":23,"timePerspective":23,"maskingInfo":34},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":35,"maskingDescription":23,"whoMasked":23},"NONE","This study is a study of SPGL-008 monotherapy in patients with advanced malignant tumors. The study includes two cohorts, Cohort 1 and Cohort 2 will be administered by intravenous and subcutaneous administration respectively. Both cohorts will be conducted by the dose-escalation design to evaluate safety, tolerability and preliminary efficacy of different administration of SPGL008.",[38,43,46,49,52,55,58,61,64,67,70,73,76,79],{"label":39,"type":40,"description":23,"interventionNames":41},"dose level 1 of SPGL008 （Intravenous administration）","EXPERIMENTAL",[42],"Drug: SPGL008",{"label":44,"type":40,"description":23,"interventionNames":45},"dose level 2 of SPGL008 （Intravenous administration）",[42],{"label":47,"type":40,"description":23,"interventionNames":48},"dose level 3 of SPGL008 （Intravenous administration）",[42],{"label":50,"type":40,"description":23,"interventionNames":51},"dose level 4 of SPGL008 （Intravenous administration）",[42],{"label":53,"type":40,"description":23,"interventionNames":54},"dose level 5 of SPGL008 （Intravenous administration）",[42],{"label":56,"type":40,"description":23,"interventionNames":57},"dose level 6 of SPGL008 （Intravenous administration）",[42],{"label":59,"type":40,"description":23,"interventionNames":60},"dose level 7 of SPGL008 （Intravenous administration）",[42],{"label":62,"type":40,"description":23,"interventionNames":63},"dose level 8 of SPGL008 （Intravenous administration）",[42],{"label":65,"type":40,"description":23,"interventionNames":66},"dose level 1 of SPGL008 （Subcutaneous administration）",[42],{"label":68,"type":40,"description":23,"interventionNames":69},"dose level 2 of SPGL008 （Subcutaneous administration）",[42],{"label":71,"type":40,"description":23,"interventionNames":72},"dose level 3 of SPGL008 （Subcutaneous administration）",[42],{"label":74,"type":40,"description":23,"interventionNames":75},"dose level 4 of SPGL008 （Subcutaneous administration）",[42],{"label":77,"type":40,"description":23,"interventionNames":78},"dose level 5 of SPGL008 （Subcutaneous administration）",[42],{"label":80,"type":40,"description":23,"interventionNames":81},"dose level 6 of SPGL008 （Subcutaneous administration）",[42],[83],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":23},"DRUG","SPGL008","Biological product",[39,65,44,68,47,71,50,74,53,77,56,80,59,62],[89],{"name":90,"role":91,"phone":92,"phoneExt":23,"email":93},"yongsheng Li","CONTACT","17784310187","lys@cqu.edu.cn",[95],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Chongqing University Cancer Hospital","RECRUITING","Chongqing","Chongqing Municipality","400030","China","CN",{"type":104,"coordinates":105},"Point",[106,107],106.55771,29.56026,{"lat":107,"lon":106},[110],{"name":111,"role":91,"phone":92,"phoneExt":23,"email":93},"yongshen LI",{"type":113,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[115],{"name":116,"class":117},"Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd.","UNKNOWN","100595865",false,"NCT07038005","A Phase I Study of SPGL008 in Subjects With Advanced Malignant Tumors","A Phase I Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SPGL008 Monotherapy for Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. Males and\u002For females, 18-75 years old;\n2. Histologically and\u002For cytologically documented advanced or metastatic malignant Tumors;\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n4. Expected survival \\>=3 months;\n5. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Known uncontrolled or symptomatic central nervous system metastatic disease;\n2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \\>1 (National Cancer Institute Common terminology Criteria \\[NCI-CTCAE\\] v.5.0);\n3. Inadequate organ or bone marrow function;\n4. Pregnant or breast-feeding woman;\n5. Known allergies, hypersensitivity, or intolerance to SPGL008.","ALL","18 Years","75 Years",{"count":128,"type":129},96,"ESTIMATED","INTERVENTIONAL",[132],"PHASE1","This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.",[135],"Advanced Malignant Tumors","2026-02-05",{"date":138,"type":139},"2026-02-09","ACTUAL",{"date":141,"type":139},"2025-07-30",{"date":143,"type":129},"2027-06-08",{"name":5,"class":6},1]