[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100437528":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":53,"centralContacts":58,"locations":64,"responsibleParty":202,"collaborators":204,"id":207,"slug":208,"hasResults":209,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":37,"eligibilityCriteria":213,"healthyVolunteers":209,"sex":214,"minAge":215,"maxAge":37,"enrollmentInfo":216,"targetDuration":37,"studyType":219,"phases":220,"briefSummary":223,"conditions":224,"keywords":231,"overallStatus":67,"whyStopped":37,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"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",[65,82,95,109,119,131,141,154,164,174,186,193],{"facility":66,"status":67,"city":68,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Tisch Cancer Institute (TCI), Icahn School of Medicine","RECRUITING","New York","10029-5674","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-74.00597,40.71427,{"lat":76,"lon":75},[79],{"name":80,"role":81,"phone":37,"phoneExt":37,"email":37},"Thomas Marron, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":83,"status":67,"city":84,"state":85,"zip":86,"country":70,"countryCode":71,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Carolina Biooncology Institute","Huntersville","North Carolina","28078",{"type":73,"coordinates":88},[89,90],-80.84285,35.41069,{"lat":90,"lon":89},[93],{"name":94,"role":81,"phone":37,"phoneExt":37,"email":37},"John Powderly, M.D., Ph.D.",{"facility":96,"status":67,"city":97,"state":98,"zip":99,"country":100,"countryCode":37,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"The Catholic University of Korea Seoul ST.MARY'S Hospital","Seoul","Banpo-daero","06591","South Korea",{"type":73,"coordinates":102},[103,104],126.9784,37.566,{"lat":104,"lon":103},[107],{"name":108,"role":81,"phone":37,"phoneExt":37,"email":37},"In Ho Kim",{"facility":110,"status":67,"city":97,"state":111,"zip":112,"country":100,"countryCode":37,"cosmosGeoPoint":113,"geoPoint":115,"contacts":116},"Seoul National University Bundang Hospital","Bundang-gu","13620",{"type":73,"coordinates":114},[103,104],{"lat":104,"lon":103},[117],{"name":118,"role":81,"phone":37,"phoneExt":37,"email":37},"EunHee Jung",{"facility":120,"status":67,"city":121,"state":121,"zip":122,"country":100,"countryCode":37,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Chungnam National University Hospital","Daejeon","65015",{"type":73,"coordinates":124},[125,126],127.38493,36.34913,{"lat":126,"lon":125},[129],{"name":130,"role":81,"phone":37,"phoneExt":37,"email":37},"HyoJin Lee, M.D., Ph.D.",{"facility":132,"status":67,"city":97,"state":133,"zip":134,"country":100,"countryCode":37,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"Samsung Medical Center","Gangnam","06351",{"type":73,"coordinates":136},[103,104],{"lat":104,"lon":103},[139],{"name":140,"role":81,"phone":37,"phoneExt":37,"email":37},"Se Hoon Park",{"facility":142,"status":67,"city":143,"state":144,"zip":145,"country":100,"countryCode":37,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"The Catholic University of Korea St. Vincent's Hospital","Suwon","Kyeonggi-do","16247",{"type":73,"coordinates":147},[148,149],127.00889,37.29111,{"lat":149,"lon":148},[152],{"name":153,"role":81,"phone":37,"phoneExt":37,"email":37},"Byoung-Yong Shim, M.D., Ph.D.",{"facility":155,"status":67,"city":97,"state":156,"zip":157,"country":100,"countryCode":37,"cosmosGeoPoint":158,"geoPoint":160,"contacts":161},"Korea University Anam Hospital","Seongbuk-gu","02841",{"type":73,"coordinates":159},[103,104],{"lat":104,"lon":103},[162],{"name":163,"role":81,"phone":37,"phoneExt":37,"email":37},"SooHyeon Lee, M.D.",{"facility":165,"status":67,"city":97,"state":166,"zip":167,"country":100,"countryCode":37,"cosmosGeoPoint":168,"geoPoint":170,"contacts":171},"Ewha Womans University Mokdong Hospital","Yangcheon-gu","07985",{"type":73,"coordinates":169},[103,104],{"lat":104,"lon":103},[172],{"name":173,"role":81,"phone":37,"phoneExt":37,"email":37},"Jeong Min Cho",{"facility":175,"status":67,"city":97,"state":37,"zip":176,"country":100,"countryCode":37,"cosmosGeoPoint":177,"geoPoint":179,"contacts":180},"Yonsei University Health System, Severance Hospital","03722",{"type":73,"coordinates":178},[103,104],{"lat":104,"lon":103},[181,183],{"name":182,"role":81,"phone":37,"phoneExt":37,"email":37},"Byoung Chul Cho, M.D., Ph.D.",{"name":184,"role":185,"phone":37,"phoneExt":37,"email":37},"Sang Joon Shin, M.D., Ph.D.","SUB_INVESTIGATOR",{"facility":175,"status":67,"city":97,"state":37,"zip":176,"country":100,"countryCode":37,"cosmosGeoPoint":187,"geoPoint":189,"contacts":190},{"type":73,"coordinates":188},[103,104],{"lat":104,"lon":103},[191],{"name":192,"role":81,"phone":37,"phoneExt":37,"email":37},"Jung-Yun Lee, M.D., Ph.D.",{"facility":194,"status":67,"city":97,"state":37,"zip":195,"country":100,"countryCode":37,"cosmosGeoPoint":196,"geoPoint":198,"contacts":199},"Asan Medical Center","05505",{"type":73,"coordinates":197},[103,104],{"lat":104,"lon":103},[200],{"name":201,"role":81,"phone":37,"phoneExt":37,"email":37},"Jae Lyun Lee, M.D., Ph.D.",{"type":203,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[205],{"name":206,"class":6},"Merck Sharp & Dohme LLC","100437528","phase-1-gi-101gi-101a-as-a-single-agent-or-in-combination-with-pembrolizumab-or-lenvatinib-in-advanced-solid-tumors-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":217,"type":218},317,"ESTIMATED","INTERVENTIONAL",[221,222],"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.",[225,226,227,228,229,230],"Advanced Solid Tumor","Metastatic Solid Tumor","Cervical Cancer","Urothelial Carcinoma","Clear Cell Renal Cell Cancer (ccRCC)","Squamous Cell Non Small Cell Lung Cancer",[232,233,234,235,236,237,45,238,239],"GI-101\u002FGI-101A","CD80-IgG4 Fc-IL2 variant","Immunotherapy","IL-2","Interleukin-2","Pembrolizumab","CPI-refractory","Immunocytokine","2026-05-13",{"date":242,"type":243},"2026-05-15","ACTUAL",{"date":245,"type":243},"2021-08-02",{"date":247,"type":218},"2028-06-30",{"name":5,"class":6},12]