[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509019":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":42,"centralContacts":47,"locations":52,"responsibleParty":89,"collaborators":37,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":37,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":37,"enrollmentInfo":100,"targetDuration":37,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":37,"overallStatus":55,"whyStopped":37,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Chugai Pharmaceutical","INDUSTRY",[8,14,18,23,27],{"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],[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","ROSE12","ROSE12 as a IV infusion",[9,15,19,24,28],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Atezolizumab","Atezolizumab as a IV infusion",[19,24,28],[43],{"name":44,"affiliation":45,"role":46},"Sponsor Chugai Pharmaceutical Co.Ltd","clinical-trials@chugai-pharm.co.jp","STUDY_DIRECTOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":37,"email":45},"Clinical trials information","CONTACT","only use Email",[53,67,77,84],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":37},"MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-95.36327,29.76328,{"lat":65,"lon":64},{"facility":68,"status":55,"city":69,"state":70,"zip":71,"country":59,"countryCode":60,"cosmosGeoPoint":72,"geoPoint":76,"contacts":37},"NEXT Oncology","Fairfax","Virginia","22031",{"type":62,"coordinates":73},[74,75],-77.30637,38.84622,{"lat":75,"lon":74},{"facility":78,"status":55,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":37,"geoPoint":37,"contacts":37},"National Cancer Center Hospital East","Kashiwa-shi","Chiba","277-8577","Japan","JP",{"facility":85,"status":55,"city":86,"state":87,"zip":88,"country":82,"countryCode":83,"cosmosGeoPoint":37,"geoPoint":37,"contacts":37},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045",{"type":90,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"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","Inclusion Criteria:\n\n* 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\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":101,"type":102},219,"ESTIMATED","INTERVENTIONAL",[105],"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.",[108],"Solid Tumor","2025-03-04",{"date":111,"type":112},"2025-03-06","ACTUAL",{"date":114,"type":112},"2023-05-24",{"date":116,"type":102},"2026-12-31",{"name":5,"class":6},4]