[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571727":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":31,"locations":37,"responsibleParty":101,"collaborators":103,"id":106,"slug":24,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":24,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":24,"enrollmentInfo":114,"targetDuration":24,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":24,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Hanmi Pharmaceutical Company Limited","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HM16390","EXPERIMENTAL","HM16390 Monotherapy",[13],"Drug: HM16390",{"label":15,"type":10,"description":16,"interventionNames":17},"HM16390 + pembrolizumab","HM16390 in combination with pembrolizumab",[13,18],"Drug: pembrolizumab",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle",[9,15],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"pembrolizumab","Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle",[15],[30],"KEYTRUDA®",[32],{"name":33,"role":34,"phone":35,"phoneExt":24,"email":36},"Young Su (Bobby) Noh","CONTACT","82-2-410-9277","63forever@hanmi.co.kr",[38,51,62,73,82,88,95],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Massachusetts General Hospital","RECRUITING","Boston","Massachusetts","02114","United States",{"type":46,"coordinates":47},"Point",[48,49],-71.05977,42.35843,{"lat":49,"lon":48},{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":44,"cosmosGeoPoint":57,"geoPoint":61,"contacts":24},"Karmanos Cancer Institute","NOT_YET_RECRUITING","Detroit","Michigan","48201",{"type":46,"coordinates":58},[59,60],-83.04575,42.33143,{"lat":60,"lon":59},{"facility":63,"status":40,"city":64,"state":65,"zip":66,"country":67,"cosmosGeoPoint":68,"geoPoint":72,"contacts":24},"Seoul National University Bundang Hospital","Seongnam-si","Gyeonggi-do","13620","South Korea",{"type":46,"coordinates":69},[70,71],127.13778,37.43861,{"lat":71,"lon":70},{"facility":74,"status":40,"city":75,"state":24,"zip":76,"country":67,"cosmosGeoPoint":77,"geoPoint":81,"contacts":24},"Seoul National University Hospital","Seoul","03080",{"type":46,"coordinates":78},[79,80],126.9784,37.566,{"lat":80,"lon":79},{"facility":83,"status":40,"city":75,"state":24,"zip":84,"country":67,"cosmosGeoPoint":85,"geoPoint":87,"contacts":24},"Severance Hospital","03722",{"type":46,"coordinates":86},[79,80],{"lat":80,"lon":79},{"facility":89,"status":90,"city":75,"state":24,"zip":91,"country":67,"cosmosGeoPoint":92,"geoPoint":94,"contacts":24},"Asan Medical Center","ACTIVE_NOT_RECRUITING","05505",{"type":46,"coordinates":93},[79,80],{"lat":80,"lon":79},{"facility":96,"status":40,"city":75,"state":24,"zip":97,"country":67,"cosmosGeoPoint":98,"geoPoint":100,"contacts":24},"Samsung Medical Center","06351",{"type":46,"coordinates":99},[79,80],{"lat":80,"lon":79},{"type":102,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[104],{"name":105,"class":6},"Merck Sharp & Dohme LLC","100571727",false,"NCT06724016","Dose Escalation and Expansion Study of HM16390 Alone or With Pembrolizumab in Advanced or Metastatic Solid Tumors","A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM16390, as a Single Agent and in Combination With Pembrolizumab, in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Have a histologically and\u002For cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit.\n* Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization.\n* Age of 18 years or older (or country's legal age of majority if the legal age was \\>18 years)\n* Adequate renal function.\n* Adequate hematologic function.\n* Adequate liver function.\n\nKey Exclusion Criteria:\n\n* Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390.\n* Known active CNS metastases and\u002For carcinomatous meningitis.\n* History of severe toxicities associated with a prior immunotherapy.\n* Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.\n* Has ongoing or suspected autoimmune disease.\n* Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.\n* History of chronic liver disease or evidence of hepatic cirrhosis.","ALL","18 Years",{"count":115,"type":116},292,"ESTIMATED","INTERVENTIONAL",[119],"PHASE1","This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors.\n\nDose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.",[122],"Advanced or Metastatic Solid Tumors","2025-12-09",{"date":125,"type":126},"2025-12-17","ACTUAL",{"date":128,"type":126},"2024-12-11",{"date":130,"type":116},"2031-07",{"name":5,"class":6},7]