[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437528":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":53,"centralContacts":58,"locations":64,"responsibleParty":201,"collaborators":203,"id":206,"slug":37,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":37,"eligibilityCriteria":211,"healthyVolunteers":207,"sex":212,"minAge":213,"maxAge":37,"enrollmentInfo":214,"targetDuration":37,"studyType":217,"phases":218,"briefSummary":221,"conditions":222,"keywords":229,"overallStatus":67,"whyStopped":37,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},{"fullName":5,"class":6},"GI Innovation, Inc.","INDUSTRY",[8,14,18,23,28],{"label":9,"type":10,"description":11,"interventionNames":12},"GI-101","EXPERIMENTAL","Dose escalation: GI-101, multiple ascending doses\n\nDose expansion:",[13],"Drug: GI-101",{"label":15,"type":10,"description":11,"interventionNames":16},"GI-101 + Pembrolizumab",[13,17],"Drug: Pembrolizumab (KEYTRUDA®)",{"label":19,"type":10,"description":20,"interventionNames":21},"GI-101 + Lenvatinib","Dose optimization:\n\nDose expansion:",[13,22],"Drug: Lenvatinib",{"label":24,"type":10,"description":25,"interventionNames":26},"GI-101A","Dose escalation: GI-101A, multiple ascending doses",[27],"Drug: GI-101A",{"label":29,"type":10,"description":30,"interventionNames":31},"GI-101A + Pembrolizumab","Dose escalation: GI-101A, multiple ascending doses Dose optimization Indication-specific cohorts",[17,27],[33,38,44,50],{"type":34,"name":9,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).",[9,19,15],null,{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Pembrolizumab (KEYTRUDA®)","Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.",[15,29],[43],"KEYTRUDA®",{"type":34,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Lenvatinib","Lenvatinib will be administered at an approved dose orally.",[19],[49],"Lenvima®",{"type":34,"name":24,"description":51,"armGroupLabels":52,"otherNames":37},"Recommended phase 2 dose of GI-101A will be administered via IV infusion Q3W up to 2 years (approximately 35 years).",[24,29],[54],{"name":55,"affiliation":56,"role":57},"Nari Yun, PhD","GI Innovation","STUDY_DIRECTOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":37,"email":63},"Recruiting sites have contact information. Please contact the sites directly.","CONTACT","+8224042003","clinical@gi-innovation.com",[65,81,94,108,118,130,140,153,163,173,185,192],{"facility":66,"status":67,"city":68,"state":68,"zip":69,"country":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Tisch Cancer Institute (TCI), Icahn School of Medicine","RECRUITING","New York","10029-5674","United States",{"type":72,"coordinates":73},"Point",[74,75],-74.00597,40.71427,{"lat":75,"lon":74},[78],{"name":79,"role":80,"phone":37,"phoneExt":37,"email":37},"Thomas Marron, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":82,"status":67,"city":83,"state":84,"zip":85,"country":70,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Carolina Biooncology Institute","Huntersville","North Carolina","28078",{"type":72,"coordinates":87},[88,89],-80.84285,35.41069,{"lat":89,"lon":88},[92],{"name":93,"role":80,"phone":37,"phoneExt":37,"email":37},"John Powderly, M.D., Ph.D.",{"facility":95,"status":67,"city":96,"state":97,"zip":98,"country":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"The Catholic University of Korea Seoul ST.MARY'S Hospital","Seoul","Banpo-daero","06591","South Korea",{"type":72,"coordinates":101},[102,103],126.9784,37.566,{"lat":103,"lon":102},[106],{"name":107,"role":80,"phone":37,"phoneExt":37,"email":37},"In Ho Kim",{"facility":109,"status":67,"city":96,"state":110,"zip":111,"country":99,"cosmosGeoPoint":112,"geoPoint":114,"contacts":115},"Seoul National University Bundang Hospital","Bundang-gu","13620",{"type":72,"coordinates":113},[102,103],{"lat":103,"lon":102},[116],{"name":117,"role":80,"phone":37,"phoneExt":37,"email":37},"EunHee Jung",{"facility":119,"status":67,"city":120,"state":120,"zip":121,"country":99,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Chungnam National University Hospital","Daejeon","65015",{"type":72,"coordinates":123},[124,125],127.38493,36.34913,{"lat":125,"lon":124},[128],{"name":129,"role":80,"phone":37,"phoneExt":37,"email":37},"HyoJin Lee, M.D., Ph.D.",{"facility":131,"status":67,"city":96,"state":132,"zip":133,"country":99,"cosmosGeoPoint":134,"geoPoint":136,"contacts":137},"Samsung Medical Center","Gangnam","06351",{"type":72,"coordinates":135},[102,103],{"lat":103,"lon":102},[138],{"name":139,"role":80,"phone":37,"phoneExt":37,"email":37},"Se Hoon Park",{"facility":141,"status":67,"city":142,"state":143,"zip":144,"country":99,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"The Catholic University of Korea St. Vincent's Hospital","Suwon","Kyeonggi-do","16247",{"type":72,"coordinates":146},[147,148],127.00889,37.29111,{"lat":148,"lon":147},[151],{"name":152,"role":80,"phone":37,"phoneExt":37,"email":37},"Byoung-Yong Shim, M.D., Ph.D.",{"facility":154,"status":67,"city":96,"state":155,"zip":156,"country":99,"cosmosGeoPoint":157,"geoPoint":159,"contacts":160},"Korea University Anam Hospital","Seongbuk-gu","02841",{"type":72,"coordinates":158},[102,103],{"lat":103,"lon":102},[161],{"name":162,"role":80,"phone":37,"phoneExt":37,"email":37},"SooHyeon Lee, M.D.",{"facility":164,"status":67,"city":96,"state":165,"zip":166,"country":99,"cosmosGeoPoint":167,"geoPoint":169,"contacts":170},"Ewha Womans University Mokdong Hospital","Yangcheon-gu","07985",{"type":72,"coordinates":168},[102,103],{"lat":103,"lon":102},[171],{"name":172,"role":80,"phone":37,"phoneExt":37,"email":37},"Jeong Min Cho",{"facility":174,"status":67,"city":96,"state":37,"zip":175,"country":99,"cosmosGeoPoint":176,"geoPoint":178,"contacts":179},"Yonsei University Health System, Severance Hospital","03722",{"type":72,"coordinates":177},[102,103],{"lat":103,"lon":102},[180,182],{"name":181,"role":80,"phone":37,"phoneExt":37,"email":37},"Byoung Chul Cho, M.D., Ph.D.",{"name":183,"role":184,"phone":37,"phoneExt":37,"email":37},"Sang Joon Shin, M.D., Ph.D.","SUB_INVESTIGATOR",{"facility":174,"status":67,"city":96,"state":37,"zip":175,"country":99,"cosmosGeoPoint":186,"geoPoint":188,"contacts":189},{"type":72,"coordinates":187},[102,103],{"lat":103,"lon":102},[190],{"name":191,"role":80,"phone":37,"phoneExt":37,"email":37},"Jung-Yun Lee, M.D., Ph.D.",{"facility":193,"status":67,"city":96,"state":37,"zip":194,"country":99,"cosmosGeoPoint":195,"geoPoint":197,"contacts":198},"Asan Medical Center","05505",{"type":72,"coordinates":196},[102,103],{"lat":103,"lon":102},[199],{"name":200,"role":80,"phone":37,"phoneExt":37,"email":37},"Jae Lyun Lee, M.D., Ph.D.",{"type":202,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[204],{"name":205,"class":6},"Merck Sharp & Dohme LLC","100437528",false,"NCT04977453","GI-101\u002FGI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors","A Phase 1\u002F2, Open-label, Dose-escalation, Dose-optimization and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101\u002FGI-101A as a Single Agent and in Combination With Pembrolizumab or Lenvatinib in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)","Key Inclusion Criteria:\n\n* Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.\n* Has adequate organ and marrow function as defined in protocol.\n* Measurable disease as per RECIST v1.1.\n* ECOG performance status 0-1.\n* Adverse events related to any prior chemotherapy, radiotherapy, immunotherapy, other prior systemic anti-cancer therapy, or surgery must have resolved to Grade ≤1, except alopecia and Grade 2 peripheral neuropathy.\n* HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection\u002Fdisease as defined in protocol.\n\nKey Exclusion Criteria:\n\n* Has known active CNS metastases and\u002For carcinomatous meningitis.\n* An active second malignancy\n* Has active or a known history of Hepatitis B or known active Hepatitis C virus infection.\n* Has active tuberculosis or has a known history of active tuberculosis\n* Active or uncontrolled infections, or severe infection within 4 weeks before study treatment administration.\n* History of chronic liver disease or evidence of hepatic cirrhosis, except patients with liver metastasis.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Previous immunotherapies related to mode of action of GI-101.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1.\n* Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.\n* Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy\n* Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.\n* Known hypersensitivity to any of the components of the drug products and\u002For excipients of GI-101\u002FGI-101A, pembrolizumab or lenvatinib.\n\nOther protocol defined inclusion exclusion criteria may apply. Cancer type and part-specific inclusion criteria are described in the study protocol.","ALL","18 Years",{"count":215,"type":216},317,"ESTIMATED","INTERVENTIONAL",[219,220],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101\u002FGI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and\u002For metastatic solid tumors.",[223,224,225,226,227,228],"Advanced Solid Tumor","Metastatic Solid Tumor","Cervical Cancer","Urothelial Carcinoma","Clear Cell Renal Cell Cancer (ccRCC)","Squamous Cell Non Small Cell Lung Cancer",[230,231,232,233,234,235,45,236,237],"GI-101\u002FGI-101A","CD80-IgG4 Fc-IL2 variant","Immunotherapy","IL-2","Interleukin-2","Pembrolizumab","CPI-refractory","Immunocytokine","2026-05-13",{"date":240,"type":241},"2026-05-15","ACTUAL",{"date":243,"type":241},"2021-08-02",{"date":245,"type":216},"2028-06-30",{"name":5,"class":6},12]