[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606226":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":65,"collaborators":19,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":19,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":19,"enrollmentInfo":76,"targetDuration":19,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":91,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"GI Innovation, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GI-108","EXPERIMENTAL","Dose escalation: GI-108 intravenous (IV), multiple ascending doses Dose optimization: GI-108 intravenous (IV), sRP2D",[13],"Drug: GI-108",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Dose level will be escalated from 0.1mg\u002Fkg to 0.6 mg\u002Fkg and Recommended phase 2 dose (or RP2D) of GI-108 will be administered via IV infusion Q3W upto 2 years (approximately 35 years)",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Seunghwan Shin, M.D.","CONTACT","+82-2-404-2003","clinical-108@gi-innovation.com",[27,44,54],{"facility":28,"status":29,"city":30,"state":19,"zip":31,"country":32,"countryCode":19,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Yonsei University Health System, Severance Hospital","RECRUITING","Seoul","03722","South Korea",{"type":34,"coordinates":35},"Point",[36,37],126.9784,37.566,{"lat":37,"lon":36},[40],{"name":41,"role":23,"phone":42,"phoneExt":19,"email":43},"Byoung Chul Cho, MD, PhD","+82-2-2228-0880","cbc1971@yuhs.ac",{"facility":45,"status":29,"city":30,"state":19,"zip":46,"country":32,"countryCode":19,"cosmosGeoPoint":47,"geoPoint":49,"contacts":50},"Asan Medical Center","05505",{"type":34,"coordinates":48},[36,37],{"lat":37,"lon":36},[51],{"name":52,"role":23,"phone":19,"phoneExt":19,"email":53},"Dae Ho Lee, MD, PhD","leedaeho@amc.seoul.kr",{"facility":55,"status":29,"city":30,"state":19,"zip":56,"country":32,"countryCode":19,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"Samsung Medical Center","06351",{"type":34,"coordinates":58},[36,37],{"lat":37,"lon":36},[61],{"name":62,"role":23,"phone":63,"phoneExt":19,"email":64},"Joon Oh Park, MD, PhD","+82-2-3410-3457","oncopark@skku.edu",{"type":66,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100606226","phase-1-a-study-of-gi-108-an-anti-cd73-igg4-fc-il-2v-bispecific-fusion-protein-as-monotherapy-in-patients-with-advanced-or-metastatic-solid-tumors-100606226",false,"NCT07172802","A Study of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as Monotherapy in Patients With Advanced or Metastatic Solid Tumors","An Open-label, Multicenter, Dose Escalation and Expansion Phase 1\u002F2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-108, an Anti-CD73-IgG4 Fc-IL-2v Bispecific Fusion Protein, as a Single Agent in Patients With Advanced or Metastatic Solid Tumors","Key Inclusion Criteria:\n\n* Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatoryguidelines) 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. 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. 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-102. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroidtherapy or any other form of immunosuppressive medications within 2 weeksprior to Cycle 1 Day 1.","ALL","18 Years",{"count":77,"type":78},76,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-108, as a single agent, in patients with advanced or metastatic solid tumors",[85,86,87,88,89,90],"Advanced Solid Tumor","Metastatic Solid Tumor","Non-small Cell Lung Cancer (NSCLC)","Head and Neck (HNSCC)","Pancreatic Cancer","Renal Cell Carcinoma (RCC)",[9],"2025-09-08",{"date":94,"type":95},"2025-09-15","ACTUAL",{"date":97,"type":95},"2025-04-22",{"date":99,"type":78},"2027-09",{"name":5,"class":6},3]