[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538654":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":56,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":25,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Dong-A ST Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Monotherapy","EXPERIMENTAL","Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Pharmacodynamic Biomarkers",[13],"Drug: DA-4505",{"label":15,"type":10,"description":16,"interventionNames":17},"Combination with Pembrolizumab","Phase 1a: Dose escalation Phase 1b: Dose expansion Phase 2a: Proof of concept Phase 2a: Pharmacodynamic Biomarkers",[18],"Drug: DA-4505 + Pembrolizumab",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","DA-4505","Phase 1a: Dose escalation Phase 1b: OBD and MTD Phase 2a: RP2D",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"DA-4505 + Pembrolizumab","Phase 1a\u002Fb: OBD, MTD of DA-4505 + 200mg of Pembrolizumab Phase 2a: RP2D of DA-4505 + 200mg of Pembrolizumab",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Jayun Jang","CONTACT","+82-2-920-8306","janycan@donga.co.kr",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},"Hye-yeong Han","hyhan@donga.co.kr",[40,51],{"facility":41,"status":42,"city":43,"state":25,"zip":25,"country":44,"countryCode":25,"cosmosGeoPoint":45,"geoPoint":50,"contacts":25},"Asan Medical Center","RECRUITING","Seoul","South Korea",{"type":46,"coordinates":47},"Point",[48,49],126.9784,37.566,{"lat":49,"lon":48},{"facility":52,"status":42,"city":43,"state":25,"zip":25,"country":44,"countryCode":25,"cosmosGeoPoint":53,"geoPoint":55,"contacts":25},"Severance Hospital",{"type":46,"coordinates":54},[48,49],{"lat":49,"lon":48},{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100538654","phase-1-clinical-trial-to-investigate-safety-tolerability-pharmacokinetics-pharmacodynamics-and-efficacy-of-da-4505-as-a-single-agent-and-in-combination-with-pembrolizumab-in-adult-patients-with-locally-advanced-or-metastatic-solid-tumors-100538654",false,"NCT06293651","Clinical Trial to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors","an Open-Label, Phase 1\u002F2a, First-in-Human Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1. Aged 18 and older.\n2. Capable of giving signed informed consent.\n3. Diagnosed with particular disease characteristics.\n4. Expected survival ≥ 3 months.\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n6. A female patient is eligible to participate if she is not pregnant or breastfeeding.\n7. A male patient is eligible to participate if he agrees to remain abstinent or use a male condom when having sexual intercourse with a WOCBP, or if he has had a bilateral vasectomy.\n8. Have measurable disease by revised RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n1. Inability to take oral medications or gastrointestinal abnormalities potentially impacting absorption.\n2. Current enrollment or past participation in another clinical trial.\n3. Unresolved adverse reactions (except alopecia) from previous cancer-directed therapy.\n4. Use of cancer-directed therapies, including chimeric antigen receptor T cell therapy.\n5. Autologous transplantation within 60 days.\n6. Prior allogeneic transplantation.\n7. Major surgery within 30 days, or unresolved complications after a major or minor surgery.\n8. History of or currently active cardiovascular disease.\n9. Clinically significant respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.\n10. History of other malignancy.","ALL","18 Years",{"count":68,"type":69},125,"ESTIMATED","INTERVENTIONAL",[72,73],"PHASE1","PHASE2","This study is an Open-Label, Phase 1\u002F2a, First-in-Human, Dose-Escalation, Dose-Expansion, and Proof-of-Concept Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of DA-4505 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Locally Advanced or Metastatic Solid Tumors.",[76],"Locally Advanced or Metastatic Solid Tumors","2025-02-10",{"date":79,"type":80},"2025-02-12","ACTUAL",{"date":82,"type":80},"2024-04-18",{"date":84,"type":69},"2029-10",{"name":5,"class":6},2]