[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555199":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":40,"locations":46,"responsibleParty":219,"collaborators":28,"id":221,"slug":222,"hasResults":223,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":28,"eligibilityCriteria":227,"healthyVolunteers":223,"sex":228,"minAge":229,"maxAge":230,"enrollmentInfo":231,"targetDuration":28,"studyType":234,"phases":235,"briefSummary":237,"conditions":238,"keywords":28,"overallStatus":49,"whyStopped":28,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"Hangzhou Sumgen Biotech Co., Ltd.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"SG301 Injection in combination with pomalidomide and dexamethasone","EXPERIMENTAL","Participants will receive SG301 Injection in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.",[13,14,15],"Drug: SG301 Injection","Drug: pomalidomide","Drug: dexamethasone",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo in combination with pomalidomide and dexamethasone","PLACEBO_COMPARATOR","Participants in Stage 2 who randomized to this arm will receive placebo in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.",[21,14,15],"Drug: SG301 placebo",[23,29,32,36],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","SG301 Injection","Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.",[9],null,{"type":24,"name":30,"description":26,"armGroupLabels":31,"otherNames":28},"SG301 placebo",[17],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":28},"pomalidomide","Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.",[17,9],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":28},"dexamethasone","Dosage form: tablets or solution for infusion Route of administration: oral or intravenous Dosage: 40 mg (participants with BMI \\\u003C 18.5 kg\u002Fm2 received 20 mg dexamethasone) Frequency: once daily on Day 1, 8, 15, 22 of each 28-day treatment cycle.",[17,9],[41],{"name":42,"role":43,"phone":44,"phoneExt":28,"email":45},"Jing Yang","CONTACT","+86 010-56315401","yangjing@sumgenbio.com",[47,66,82,92,107,121,136,151,166,180,195,204],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Beijing Chaoyang Hospital of Capital Medical University","RECRUITING","Beijing","Beijing Municipality","100024","China","CN",{"type":56,"coordinates":57},"Point",[58,59],116.39723,39.9075,{"lat":59,"lon":58},[62,64],{"name":63,"role":43,"phone":28,"phoneExt":28,"email":28},"Wenming Chen, Doctor",{"name":65,"role":43,"phone":28,"phoneExt":28,"email":28},"Ying Tian",{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":53,"countryCode":54,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Guangzhou First People's Hospital","NOT_YET_RECRUITING","Guangzhou","Guangdong","510000",{"type":56,"coordinates":73},[74,75],113.25,23.11667,{"lat":75,"lon":74},[78,80],{"name":79,"role":43,"phone":28,"phoneExt":28,"email":28},"Shunqing Wang",{"name":81,"role":43,"phone":28,"phoneExt":28,"email":28},"Wei Zhou",{"facility":83,"status":68,"city":69,"state":70,"zip":71,"country":53,"countryCode":54,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Sun Yat-sen University Cancer Center",{"type":56,"coordinates":85},[74,75],{"lat":75,"lon":74},[88,90],{"name":89,"role":43,"phone":28,"phoneExt":28,"email":28},"Zhongjun Xia",{"name":91,"role":43,"phone":28,"phoneExt":28,"email":28},"Xiaoqin Chen",{"facility":93,"status":49,"city":94,"state":95,"zip":96,"country":53,"countryCode":54,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"First Affiliated Hospital of Henan University of Science and Technology","Luoyang","Henan","471000",{"type":56,"coordinates":98},[99,100],112.43684,34.67345,{"lat":100,"lon":99},[103,105],{"name":104,"role":43,"phone":28,"phoneExt":28,"email":28},"Haiping Yang",{"name":106,"role":43,"phone":28,"phoneExt":28,"email":28},"Bingke Zhu",{"facility":108,"status":49,"city":109,"state":95,"zip":110,"country":53,"countryCode":54,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Henan Cancer Hospital","Zhengzhou","450000",{"type":56,"coordinates":112},[113,114],113.64861,34.75778,{"lat":114,"lon":113},[117,119],{"name":118,"role":43,"phone":28,"phoneExt":28,"email":28},"Baijun Fang",{"name":120,"role":43,"phone":28,"phoneExt":28,"email":28},"Yuzhang Liu",{"facility":122,"status":49,"city":123,"state":124,"zip":125,"country":53,"countryCode":54,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430000",{"type":56,"coordinates":127},[128,129],114.26667,30.58333,{"lat":129,"lon":128},[132,134],{"name":133,"role":43,"phone":28,"phoneExt":28,"email":28},"Chunyan Sun",{"name":135,"role":43,"phone":28,"phoneExt":28,"email":28},"Fei Zhao",{"facility":137,"status":49,"city":138,"state":139,"zip":140,"country":53,"countryCode":54,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"The First Affiliated Hospital Of Soochow University","Suzhou","Jiangsu","215006",{"type":56,"coordinates":142},[143,144],120.59538,31.30408,{"lat":144,"lon":143},[147,149],{"name":148,"role":43,"phone":28,"phoneExt":28,"email":28},"ZhengZheng Fu",{"name":150,"role":43,"phone":28,"phoneExt":28,"email":28},"Yingying Zhai",{"facility":152,"status":49,"city":153,"state":154,"zip":155,"country":53,"countryCode":54,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Shanxi Provincial Hospital","Taiyuan","Shanxi","030000",{"type":56,"coordinates":157},[158,159],112.56028,37.86944,{"lat":159,"lon":158},[162,164],{"name":163,"role":43,"phone":28,"phoneExt":28,"email":28},"Liping Su",{"name":165,"role":43,"phone":28,"phoneExt":28,"email":28},"Jingrong Wang",{"facility":167,"status":49,"city":168,"state":154,"zip":169,"country":53,"countryCode":54,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)","Xi’an","710000",{"type":56,"coordinates":171},[172,173],113.52486,35.99785,{"lat":173,"lon":172},[176,178],{"name":177,"role":43,"phone":28,"phoneExt":28,"email":28},"Wanhong Zhao",{"name":179,"role":43,"phone":28,"phoneExt":28,"email":28},"Fangxia Wang",{"facility":181,"status":49,"city":182,"state":183,"zip":184,"country":53,"countryCode":54,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Tianjin Cancer University Airport Hospital","Tianjin","Tianjin Municipality","300060",{"type":56,"coordinates":186},[187,188],117.17667,39.14222,{"lat":188,"lon":187},[191,193],{"name":192,"role":43,"phone":28,"phoneExt":28,"email":28},"Yafei Wang",{"name":194,"role":43,"phone":28,"phoneExt":28,"email":28},"Zhiying Zhang",{"facility":196,"status":68,"city":182,"state":183,"zip":184,"country":53,"countryCode":54,"cosmosGeoPoint":197,"geoPoint":199,"contacts":200},"Tianjin Medical University Cancer Institute & Hospital",{"type":56,"coordinates":198},[187,188],{"lat":188,"lon":187},[201,202],{"name":192,"role":43,"phone":28,"phoneExt":28,"email":28},{"name":203,"role":43,"phone":28,"phoneExt":28,"email":28},"Haifeng Zhao",{"facility":205,"status":49,"city":206,"state":207,"zip":208,"country":53,"countryCode":54,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"The Second Affiliated Hospital Zhejiang University School Of Medicine","Hangzhou","Zhejiang","310056",{"type":56,"coordinates":210},[211,212],120.16142,30.29365,{"lat":212,"lon":211},[215,217],{"name":216,"role":43,"phone":28,"phoneExt":28,"email":28},"Wenbin Qian",{"name":218,"role":43,"phone":28,"phoneExt":28,"email":28},"Xuzhao Zhang",{"type":220,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100555199","phase-3-a-clinical-study-comparing-sg301-plus-pomalidomide-and-dexamethasone-to-placebo-plus-pomalidomide-and-dexamethasone-in-relapsed-or-refractory-multiple-myeloma-patients-100555199",false,"NCT06508983","A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients","A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n1. Understand and voluntarily sign the informed consent form (ICF).\n2. Males and females aged 18-75 years (inclusive)\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2\n4. Expected survival time of ≥3 months.\n5. Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease.\n6. Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.\n7. Subjects must have documented evidence of PD on or after the last regimen.\n8. Adequate function of vital organs\n9. Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment.\n\nExclusion Criteria:\n\n1. Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.\n2. Bone independent extramedullary disease at screening.\n3. Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.\n4. Previous exposure to pomalidomide.\n5. Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;\n6. Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;\n7. Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment;\n8. Active hepatitis B, or C.\n9. Known HIV infection.\n10. Known active tuberculosis or positive treponema pallidum antibodies.\n11. Subjects with clinical significant organ dysfunction that does not meet the study needs.\n12. Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.\n13. Known allergy to any component of the investigational medicinal product.\n14. Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.","ALL","18 Years","75 Years",{"count":232,"type":233},360,"ESTIMATED","INTERVENTIONAL",[236],"PHASE3","The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.",[239],"Relapsed\u002FRefractory Multiple Myeloma","2025-06-24",{"date":242,"type":243},"2025-06-27","ACTUAL",{"date":245,"type":243},"2024-06-14",{"date":247,"type":233},"2028-03-31",{"name":5,"class":6},12]