[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471775":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":48,"locations":54,"responsibleParty":161,"collaborators":33,"id":163,"slug":164,"hasResults":165,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":33,"eligibilityCriteria":169,"healthyVolunteers":165,"sex":170,"minAge":171,"maxAge":33,"enrollmentInfo":172,"targetDuration":33,"studyType":175,"phases":176,"briefSummary":179,"conditions":180,"keywords":183,"overallStatus":57,"whyStopped":33,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Toray Industries, Inc","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 : TRK-950","EXPERIMENTAL","* Solid Tumor\n* TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle. Two dose levels will be explored during this Arm.",[13],"Biological: TRK-950",{"label":15,"type":10,"description":16,"interventionNames":17},"Part 2 Cohort 1: TRK-950+Nivolumab","* Nivolumab-eligible solid tumor\n* Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1, 8, 15 and 22. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.",[13,18],"Drug: Nivolumab",{"label":20,"type":10,"description":21,"interventionNames":22},"Part 2 Cohort 2: TRK-950+Nivolumab","* Nivolumab-eligible solid tumor\n* Nivolumab will be administered intravenously on days 1 and 15 of a 28-day cycle. TRK-950 will be administered as an intravenously infusion on days 1 and 15. After the administration of Nivolumab on days 1 and 15, TRK-950 will be administered as an intravenously infusion.",[13,18],{"label":24,"type":10,"description":25,"interventionNames":26},"Part 3: TRK-950","* Melanoma\n* TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle.",[13],[28,34,37,40,45],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","TRK-950","5 or 10 mg\u002Fkg administered intravenously over 60 minutes (weekly)",[9],null,{"type":29,"name":30,"description":35,"armGroupLabels":36,"otherNames":33},"10 mg\u002Fkg administered intravenously over 60 minutes (weekly)",[15],{"type":29,"name":30,"description":38,"armGroupLabels":39,"otherNames":33},"20 mg\u002Fkg administered intravenously over 60 minutes (bi-weekly)",[20],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":33},"DRUG","Nivolumab","240 mg administered intravenously over 30 minutes 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Center","Fukuoka","811-1395",{"type":64,"coordinates":77},[78,79],130.41667,33.6,{"lat":79,"lon":78},[82],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"facility":84,"status":57,"city":85,"state":86,"zip":87,"country":61,"countryCode":62,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Sapporo Medical University Hospital","Sapporo","Hokkaido","060-8543",{"type":64,"coordinates":89},[90,91],141.35,43.06667,{"lat":91,"lon":90},[94],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"facility":96,"status":57,"city":97,"state":97,"zip":98,"country":61,"countryCode":62,"cosmosGeoPoint":99,"geoPoint":103,"contacts":104},"Kumamoto University Hospital","Kumamoto","860-8556",{"type":64,"coordinates":100},[101,102],130.69181,32.80589,{"lat":102,"lon":101},[105],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"facility":107,"status":57,"city":108,"state":109,"zip":110,"country":61,"countryCode":62,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Shinshu University Hospital","Matsumoto","Nagano","390-8621",{"type":64,"coordinates":112},[113,114],137.96667,36.23333,{"lat":114,"lon":113},[117],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"facility":119,"status":57,"city":120,"state":120,"zip":121,"country":61,"countryCode":62,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Niigata Cancer Center Hospital","Niigata","951-8566",{"type":64,"coordinates":123},[124,125],139.04125,37.92259,{"lat":125,"lon":124},[128],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"facility":130,"status":57,"city":131,"state":132,"zip":133,"country":61,"countryCode":62,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Saitama Medical University International Medical Center","Hidaka","Saitama","350-1298",{"type":64,"coordinates":135},[136,137],139.36233,35.91664,{"lat":137,"lon":136},[140],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"facility":142,"status":57,"city":143,"state":144,"zip":145,"country":61,"countryCode":62,"cosmosGeoPoint":33,"geoPoint":33,"contacts":146},"Shizuoka Cancer Center","Nagaizumi-chō","Shizuoka","411-8777",[147],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"facility":149,"status":57,"city":150,"state":151,"zip":152,"country":61,"countryCode":62,"cosmosGeoPoint":33,"geoPoint":33,"contacts":153},"National Cancer Center Hospital","Chuo Ku","Tokyo","104-0045",[154],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"facility":156,"status":57,"city":157,"state":151,"zip":158,"country":61,"countryCode":62,"cosmosGeoPoint":33,"geoPoint":33,"contacts":159},"Keio University Hospital","Shinjuku-Ku","160-8582",[160],{"name":71,"role":51,"phone":33,"phoneExt":33,"email":33},{"type":162,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100471775","phase-1-a-study-of-trk-950-in-patients-with-advanced-solid-tumors-100471775",false,"NCT05423262","A Study of TRK-950 in Patients With Advanced Solid Tumors","A Phase I\u002FII Study of TRK-950 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Part 1: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who have been refractory or intolerant to standard therapies or for whom no standard therapy exists. Part 2: Patients with histologically and cytologically confirmed locally advanced or metastatic solid tumors who are eligible for standard therapy with NIVO 240 mg alone administered at 2-week intervals.\n* Part 3: Patients with histologically confirmed locally advanced unresectable or metastatic melanoma (excluding uveal melanoma), who received prior chemotherapy with DTIC and for whom no standard therapy exists\n* Patients with life expectancy of at least 3 months after the start of study drug administration\n* Patients aged \\>=18 years at the time of consent\n* Patients who are able to provide written consent in person to be a subject of this study\n* A negative pregnancy test before enrollment (if female of childbearing potential)\n\nExclusion Criteria:\n\n* Patients with active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n* Pregnant women (including those who are considered possibly pregnant based on history taking, etc. by physician) or breastfeeding women (interrupting breastfeeding to enroll is also not allowed)\n* Patients who are unwilling or unable to comply with the protocol specified procedures\n* Patients who are positive for human immunodeficiency virus (HIV) antibody\n* Patients who meet any of the following conditions on hepatitis B virus (HBV) and hepatitis C virus (HCV) testing\n\n  * Patients who are positive for hepatitis B surface antigen (HBsAg)\n  * Patients who are positive for HCV RNA","ALL","18 Years",{"count":173,"type":174},49,"ESTIMATED","INTERVENTIONAL",[177,178],"PHASE1","PHASE2","Part 1\n\n• To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors\n\nPart 2\n\n• To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy\n\nPart 3\n\n• To determine the efficacy of TRK-950 in patients with advanced\u002Frecurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists",[181,182],"Solid Tumor","Melanoma",[184,182],"Nivolumab-eligible solid tumor","2026-04-06",{"date":187,"type":188},"2026-04-13","ACTUAL",{"date":190,"type":188},"2022-07-06",{"date":192,"type":174},"2027-12",{"name":5,"class":6},10]