[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509019":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":51,"centralContacts":56,"locations":61,"responsibleParty":174,"collaborators":42,"id":176,"slug":177,"hasResults":178,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":42,"eligibilityCriteria":182,"healthyVolunteers":178,"sex":183,"minAge":184,"maxAge":42,"enrollmentInfo":185,"targetDuration":42,"studyType":188,"phases":189,"briefSummary":191,"conditions":192,"keywords":42,"overallStatus":64,"whyStopped":42,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"Chugai Pharmaceutical","INDUSTRY",[8,14,18,23,27,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Dose-escalation part of Phase Ia","EXPERIMENTAL","Patients will receive ROSE12 as a IV infusion at escalated doses.",[13],"Drug: ROSE12",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B: Biopsy part of Phase Ia","Serial biopsy will be conducted with patients who will receive ROSE12 as a IV infusion at escalated doses.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part C: Dose-escalation part of Phase Ib","Patients will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.",[13,22],"Drug: Atezolizumab",{"label":24,"type":10,"description":25,"interventionNames":26},"Part D: Biopsy part of Phase Ib","Serial biopsy will be conducted with patients who will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.",[13,22],{"label":28,"type":10,"description":29,"interventionNames":30},"Part E: Expansion part of Phase Ib in patients with selected solid tumors","Patients will receive ROSE12 and atezolizumab as a IV infusion at the recommended dose.",[13,22],{"label":32,"type":10,"description":33,"interventionNames":34},"Part F: Expansion part of Phase Ib in patients with selected solid tumors","Patients will receive ROSE12 and pembrolizumab as a IV infusion at the recommended dose.",[13,35],"Drug: Pembrolizumab",[37,43,47],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","ROSE12","ROSE12 as a IV infusion",[9,15,19,24,28,32],null,{"type":38,"name":44,"description":45,"armGroupLabels":46,"otherNames":42},"Atezolizumab","Atezolizumab as a IV infusion",[19,24,28],{"type":38,"name":48,"description":49,"armGroupLabels":50,"otherNames":42},"Pembrolizumab","Pembrolizumab as a IV infusion",[32],[52],{"name":53,"affiliation":54,"role":55},"Sponsor Chugai Pharmaceutical Co.Ltd","clinical-trials@chugai-pharm.co.jp","STUDY_DIRECTOR",[57],{"name":58,"role":59,"phone":60,"phoneExt":42,"email":54},"Clinical trials information","CONTACT","only use Email",[62,76,86,96,106,116,128,133,143,148,156,160,165,170],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":42},"University of Pennsylvania Perelman Center for Advanced Medicine","RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-75.16362,39.95238,{"lat":74,"lon":73},{"facility":77,"status":64,"city":78,"state":79,"zip":80,"country":68,"countryCode":69,"cosmosGeoPoint":81,"geoPoint":85,"contacts":42},"Rhode Island Hospital","Providence","Rhode Island","02903",{"type":71,"coordinates":82},[83,84],-71.41283,41.82399,{"lat":84,"lon":83},{"facility":87,"status":64,"city":88,"state":89,"zip":90,"country":68,"countryCode":69,"cosmosGeoPoint":91,"geoPoint":95,"contacts":42},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":71,"coordinates":92},[93,94],-86.78444,36.16589,{"lat":94,"lon":93},{"facility":97,"status":64,"city":98,"state":99,"zip":100,"country":68,"countryCode":69,"cosmosGeoPoint":101,"geoPoint":105,"contacts":42},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":71,"coordinates":102},[103,104],-95.36327,29.76328,{"lat":104,"lon":103},{"facility":107,"status":64,"city":108,"state":109,"zip":110,"country":68,"countryCode":69,"cosmosGeoPoint":111,"geoPoint":115,"contacts":42},"NEXT Oncology","Fairfax","Virginia","22031",{"type":71,"coordinates":112},[113,114],-77.30637,38.84622,{"lat":114,"lon":113},{"facility":117,"status":64,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":127,"contacts":42},"Aichi Cancer Center","Nagoya","Aichi-ken","464-8681","Japan","JP",{"type":71,"coordinates":124},[125,126],136.90641,35.18147,{"lat":126,"lon":125},{"facility":129,"status":64,"city":130,"state":131,"zip":132,"country":121,"countryCode":122,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"National Cancer Center Hospital East","Kashiwa-shi","Chiba","277-8577",{"facility":134,"status":64,"city":135,"state":136,"zip":137,"country":121,"countryCode":122,"cosmosGeoPoint":138,"geoPoint":142,"contacts":42},"Kanagawa Cancer Center","Yokohama","Kanagawa","241-8515",{"type":71,"coordinates":139},[140,141],139.65,35.43333,{"lat":141,"lon":140},{"facility":144,"status":64,"city":145,"state":146,"zip":147,"country":121,"countryCode":122,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"Kansai Medical University Hospital","Hirakata-shi","Osaka","573-1191",{"facility":149,"status":64,"city":146,"state":146,"zip":150,"country":121,"countryCode":122,"cosmosGeoPoint":151,"geoPoint":155,"contacts":42},"Osaka International Cancer Institute","541-8567",{"type":71,"coordinates":152},[153,154],135.50107,34.69379,{"lat":154,"lon":153},{"facility":157,"status":64,"city":158,"state":146,"zip":159,"country":121,"countryCode":122,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"Kindai University Hospital","Sakai-shi","590-0197",{"facility":161,"status":64,"city":162,"state":163,"zip":164,"country":121,"countryCode":122,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"Shizuoka Cancer Center","Nagaizumi-chō","Shizuoka","411-8777",{"facility":166,"status":64,"city":167,"state":168,"zip":169,"country":121,"countryCode":122,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045",{"facility":171,"status":64,"city":172,"state":168,"zip":173,"country":121,"countryCode":122,"cosmosGeoPoint":42,"geoPoint":42,"contacts":42},"The Cancer Institute Hospital of JFCR","Koto-Ku","135-8550",{"type":175,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100509019","phase-1-a-phase-i-study-of-rose12-alone-and-in-combination-with-other-anti-tumor-agents-in-patients-with-solid-tumors-100509019",false,"NCT05907980","A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors","A Phase Ia\u002FIb Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of ROSE12 as a Single Agent and in Combination With Other Anti-tumor Agents in Patients With Locally Advanced or Metastatic Solid Tumors","* Age \\>= 18 years at time of signing informed consent form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1\n* Adequate hematologic and end-organ function\n* Life expectancy \\>= 12 weeks\n* Patients with histologic documentation of locally advanced, or metastatic solid tumor\n* \\[Dose-escalation Parts and Biopsy Parts\\]Refractory or resistant to standard therapies or standard therapies are not available\n* \\[Dose-escalation Parts and Expansion Part\\] Patients with confirmed availability of fresh tumor or representative tumor specimens\n* \\[Biopsy Parts\\] Patients with accessible lesion(s)\n* \\[Expansion Parts\\] Patients with ICI (immune checkpoint inhibitor)-refractory 2L-3L NSCLC (non-small-cell lung cancer) and 3L+ CRC (colorectal cancer)\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular or liver disease\n* Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug\n* Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).\n* All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy\n* Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Active or history of clinically significant autoimmune disease\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.\n\n\\[Expansion Part\\]\n\n* Prior treatment with investigational product which has MoA of Treg depletion\n* Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1","ALL","18 Years",{"count":186,"type":187},209,"ESTIMATED","INTERVENTIONAL",[190],"PHASE1","This is a Phase Ia\u002FIb open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.",[193],"Solid Tumor","2026-07-26",{"date":196,"type":197},"2026-07-28","ACTUAL",{"date":199,"type":197},"2023-05-24",{"date":201,"type":187},"2027-10-31",{"name":5,"class":6},14]