[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100471775":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":67,"studyPopulation":30,"armGroups":68,"interventions":88,"overallOfficials":30,"centralContacts":108,"locations":114,"responsibleParty":221,"collaborators":30,"id":223,"slug":30,"hasResults":224,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":30,"eligibilityCriteria":228,"healthyVolunteers":224,"sex":229,"minAge":230,"maxAge":30,"enrollmentInfo":231,"targetDuration":30,"studyType":234,"phases":235,"briefSummary":238,"conditions":239,"keywords":242,"overallStatus":117,"whyStopped":30,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},{"fullName":5,"class":6},"Toray Industries, Inc","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":30},[9,13,17,20,23],{"measure":10,"description":11,"timeFrame":12},"Number of participants with dose-limiting toxicities (DLTs) (Part 1 and 2)","Number of participants with DLTs will be determined.","Up to Day 28",{"measure":14,"description":15,"timeFrame":16},"Number of participants with adverse events (AEs) (Part 1 and 2)","Number of participants with AEs will be assessed.","through study completion, an average of 1 year",{"measure":18,"description":19,"timeFrame":16},"Number of participants with adverse events of special interest (AESIs) (Part 1 and 2)","Number of participants with AESIs will be assessed.",{"measure":21,"description":22,"timeFrame":16},"Number of participants with serious adverse events (SAEs) (Part 1 and 2)","Number of participants with SAEs will be assessed.",{"measure":24,"description":25,"timeFrame":26},"Objective response rate (ORR) (Part 3)","Objective response rate (ORR) is defined as the percentage of patients who achieved either complete response (CR) or partial response (PR) as assessed by independent central review (ICR) per RECIST Version 1.1.","Up to approximately 12 months",[28,31,33,35,37,39,41,43,46,49,52,55,58],{"measure":29,"description":30,"timeFrame":16},"Area under the concentration curve (AUC) of TRK-950 (Part 1 and 2)",null,{"measure":32,"description":30,"timeFrame":16},"Maximum plasma concentration (Cmax) of TRK-950 (Part 1 and 2)",{"measure":34,"description":30,"timeFrame":16},"Time to maximum plasma concentration (Tmax) of TRK-950 (Part 1 and 2)",{"measure":36,"description":30,"timeFrame":16},"Terminal elimination half life (t1\u002F2) of TRK-950 (Part 1 and 2)",{"measure":38,"description":30,"timeFrame":16},"Total body clearance (CL) of TRK-950 (Part 1 and 2)",{"measure":40,"description":30,"timeFrame":16},"Apparent volume of distribution (Vd) of TRK-950 (Part 1 and 2)",{"measure":42,"description":30,"timeFrame":16},"Area under the concentration curve (AUC) of Nivolumab (Part 2 only)",{"measure":44,"description":45,"timeFrame":26},"Overall survival (OS) (Part 3)","Overall survival (OS) is defined as time from the first date of TRK-950 administration until the date of death due to any cause.",{"measure":47,"description":48,"timeFrame":26},"Progression-free survival (PFS) (Part 3)","Progression-free survival (PFS) is defined as time from the first date of TRK-950 administration until progression per RECIST Version 1.1, or death due to any cause.",{"measure":50,"description":51,"timeFrame":26},"Best overall response (BOR) (Part 3)","Best overall response (BOR) is defined as the best response among all responses at each time point from the first date of TRK-950 administration until progression per RECIST Version 1.1.",{"measure":53,"description":54,"timeFrame":26},"Disease control rate (DCR) (Part 3)","Disease control rate (DCR) is defined as the percentage of patients with BOR of CR or PR or stable disease (SD) per RECIST Version 1.1.",{"measure":56,"description":57,"timeFrame":26},"Duration of response (DOR) (Part 3)","Duration of response (DOR) is defined as the duration between the date of first documented response (CR or PR) and the date of progression per RECIST Version 1.1, or death due to any cause.",{"measure":59,"description":60,"timeFrame":26},"Tumor change rate (Part 3)","Tumor change rate is defined as the percentage change in the sum of the longest diameters of target lesions, as assessed per RECIST Version 1.1, compared to baseline obtained at screening.",{"allocation":62,"interventionModel":63,"interventionModelDescription":30,"primaryPurpose":64,"observationalModel":30,"timePerspective":30,"maskingInfo":65},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":66,"maskingDescription":30,"whoMasked":30},"NONE","This is an open-label phase I\u002FII study and consists of three parts. In 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 will receive two dose level of TRK-950. In 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 will receive two dose level of TRK-950 in combination with Nivolumab. In 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 will receive one dose level of TRK-950. The objectives of this study are to determine the safety, tolerability, pharmacokinetic (PK) profile and the incidence of the development of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against TRK-950.",[69,75,80,84],{"label":70,"type":71,"description":72,"interventionNames":73},"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.",[74],"Biological: TRK-950",{"label":76,"type":71,"description":77,"interventionNames":78},"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.",[74,79],"Drug: Nivolumab",{"label":81,"type":71,"description":82,"interventionNames":83},"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.",[74,79],{"label":85,"type":71,"description":86,"interventionNames":87},"Part 3: TRK-950","* Melanoma\n* TRK-950 will be administered intravenously on days 1, 8, 15, and 22 of a 28-day cycle.",[74],[89,94,97,100,105],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":30},"BIOLOGICAL","TRK-950","5 or 10 mg\u002Fkg administered intravenously over 60 minutes (weekly)",[70],{"type":90,"name":91,"description":95,"armGroupLabels":96,"otherNames":30},"10 mg\u002Fkg administered intravenously over 60 minutes (weekly)",[76],{"type":90,"name":91,"description":98,"armGroupLabels":99,"otherNames":30},"20 mg\u002Fkg administered intravenously over 60 minutes (bi-weekly)",[81],{"type":101,"name":102,"description":103,"armGroupLabels":104,"otherNames":30},"DRUG","Nivolumab","240 mg administered intravenously over 30 minutes (bi-weekly)",[76,81],{"type":90,"name":91,"description":106,"armGroupLabels":107,"otherNames":30},"10 mg\u002Fkg administered Intravenously over 60 minutes (weekly)",[85],[109],{"name":110,"role":111,"phone":112,"phoneExt":30,"email":113},"Toray Contact for Clinical Trial Information","CONTACT","+81467-32-9948","npdd-clinical.toray.mb@mail.toray",[115,132,143,155,166,178,189,201,208,215],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"Nagoya City University Hospital","RECRUITING","Nagoya","Aichi-ken","467-8602","Japan","JP",{"type":124,"coordinates":125},"Point",[126,127],136.90641,35.18147,{"lat":127,"lon":126},[130],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},"Principal Investigator",{"facility":133,"status":117,"city":134,"state":134,"zip":135,"country":121,"countryCode":122,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"National Hospital Organization Kyushu Cancer Center","Fukuoka","811-1395",{"type":124,"coordinates":137},[138,139],130.41667,33.6,{"lat":139,"lon":138},[142],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"facility":144,"status":117,"city":145,"state":146,"zip":147,"country":121,"countryCode":122,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Sapporo Medical University Hospital","Sapporo","Hokkaido","060-8543",{"type":124,"coordinates":149},[150,151],141.35,43.06667,{"lat":151,"lon":150},[154],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"facility":156,"status":117,"city":157,"state":157,"zip":158,"country":121,"countryCode":122,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Kumamoto University Hospital","Kumamoto","860-8556",{"type":124,"coordinates":160},[161,162],130.69181,32.80589,{"lat":162,"lon":161},[165],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"facility":167,"status":117,"city":168,"state":169,"zip":170,"country":121,"countryCode":122,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Shinshu University Hospital","Matsumoto","Nagano","390-8621",{"type":124,"coordinates":172},[173,174],137.96667,36.23333,{"lat":174,"lon":173},[177],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"facility":179,"status":117,"city":180,"state":180,"zip":181,"country":121,"countryCode":122,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Niigata Cancer Center Hospital","Niigata","951-8566",{"type":124,"coordinates":183},[184,185],139.04125,37.92259,{"lat":185,"lon":184},[188],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"facility":190,"status":117,"city":191,"state":192,"zip":193,"country":121,"countryCode":122,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Saitama Medical University International Medical Center","Hidaka","Saitama","350-1298",{"type":124,"coordinates":195},[196,197],139.36233,35.91664,{"lat":197,"lon":196},[200],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"facility":202,"status":117,"city":203,"state":204,"zip":205,"country":121,"countryCode":122,"cosmosGeoPoint":30,"geoPoint":30,"contacts":206},"Shizuoka Cancer Center","Nagaizumi-chō","Shizuoka","411-8777",[207],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"facility":209,"status":117,"city":210,"state":211,"zip":212,"country":121,"countryCode":122,"cosmosGeoPoint":30,"geoPoint":30,"contacts":213},"National Cancer Center Hospital","Chuo Ku","Tokyo","104-0045",[214],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"facility":216,"status":117,"city":217,"state":211,"zip":218,"country":121,"countryCode":122,"cosmosGeoPoint":30,"geoPoint":30,"contacts":219},"Keio University Hospital","Shinjuku-Ku","160-8582",[220],{"name":131,"role":111,"phone":30,"phoneExt":30,"email":30},{"type":222,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","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":232,"type":233},49,"ESTIMATED","INTERVENTIONAL",[236,237],"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",[240,241],"Solid Tumor","Melanoma",[243,241],"Nivolumab-eligible solid tumor","2026-04-06",{"date":246,"type":247},"2026-04-13","ACTUAL",{"date":249,"type":247},"2022-07-06",{"date":251,"type":233},"2027-12",{"name":5,"class":6},10]