[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609519":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":25,"enrollmentInfo":58,"targetDuration":25,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":34,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Chong Kun Dang Pharmaceutical","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Monotherapy","EXPERIMENTAL","Dose Level(DL) 1 to DL 6",[13],"Drug: CKD-512",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B: Combination therapy","DL N to DL N+2, combination with Pembrolizumab",[13,18],"Combination Product: Pembrolizumab",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","CKD-512","Orally administered BID",[9,15],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"COMBINATION_PRODUCT","Pembrolizumab","Intravenous (IV) Infusion",[15],[32],{"facility":33,"status":34,"city":35,"state":25,"zip":25,"country":36,"countryCode":25,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Severance Hospital, Yonsei University Health System","RECRUITING","Seoul","South Korea",{"type":38,"coordinates":39},"Point",[40,41],126.9784,37.566,{"lat":41,"lon":40},[44],{"name":33,"role":45,"phone":46,"phoneExt":25,"email":25},"CONTACT","82-2-2228-1004",{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100609519","phase-1-phase-iaib-study-of-ckd-512-alone-and-in-combination-with-pembrolizumab-in-subjects-with-advanced-or-metastatic-solid-tumors-100609519",false,"NCT07215637","Phase Ia\u002FIb Study of CKD-512 Alone and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumors","A Multicenter, Open-label, Dose-escalation, Phase Ia\u002FIb Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of CKD-512 Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced or Metastatic Solid Tumor","Inclusion Criteria:\n\n* Histologically confirmed advanced or metastatic solid tumors.\n* Progressive disease after or intolerance to standard therapy and no other effective therapeutic options available.\n* Measurable disease as defined in Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Suitable venous access for the study-required blood sampling, including PK and PD sampling.\n* Adequate clinical laboratory values and other measures\n\nExclusion Criteria:\n\n* Active disease involvement of the central nervous system.\n* Any serious or life-threatening medical condition unrelated to cancer, psychiatric illness, drug or alcohol abuse, that could, in the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n* Systemic anticancer treatment within the protocol-specified period prior to the first dose.\n* History of any immune-related toxicity that lead to permanent discontinuation of prior anticancer therapy\n* Radiation therapy on a limited area is allowed until 4 weeks prior to the first dose of study drug, provided that the radiated lesion is clinically stable.\n* Prior treatment with investigational agents ≤21 days before the first dose of study drug(s).","ALL","18 Years",{"count":59,"type":60},60,"ESTIMATED","INTERVENTIONAL",[63],"PHASE1","The purpose of this first-in-human (FiH) study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of CKD-512 given alone and in combination with pembrolizumab in subjects with advanced or metastatic solid tumors who have failed all standard available therapy.",[66,67],"Advanced Solid Tumors","Metastatic Solid Tumors",[69,70,22,66,67],"A2aR","adenosine A2A receptor","2026-01-29",{"date":73,"type":74},"2026-02-02","ACTUAL",{"date":76,"type":74},"2025-10-16",{"date":78,"type":60},"2027-09",{"name":5,"class":6},1]