[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502647":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":80,"centralContacts":84,"locations":92,"responsibleParty":220,"collaborators":222,"id":225,"slug":21,"hasResults":226,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":21,"eligibilityCriteria":230,"healthyVolunteers":226,"sex":231,"minAge":232,"maxAge":21,"enrollmentInfo":233,"targetDuration":21,"studyType":236,"phases":237,"briefSummary":240,"conditions":241,"keywords":251,"overallStatus":95,"whyStopped":21,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"fullName":5,"class":6},"GI Innovation, Inc.","INDUSTRY",[8,14,19,24,29,33,37],{"label":9,"type":10,"description":11,"interventionNames":12},"GI-102","EXPERIMENTAL","Dose escalation: GI-102 intravenous (IV), multiple ascending doses Dose optimization: GI-102 intravenous (IV), sRP2D Dose optimization: GI-102 intravenous (IV), sRP2D-1 (or sRP2D+1)",[13],"Drug: GI-102",{"label":15,"type":10,"description":16,"interventionNames":17},"GI-102 subcutaneous (SC)","Dose escalation: GI-102 subcutaneous (SC), multiple ascending doses Dose expansion: GI-102 subcutaneous (SC), sRP2D",[18],"Drug: GI-102 subcutaneous (SC)",{"label":20,"type":10,"description":21,"interventionNames":22},"GI-102 + doxorubicin",null,[23,13],"Drug: doxorubicin",{"label":25,"type":10,"description":21,"interventionNames":26},"GI-102 + paclitaxel + bevacizumab",[27,28,13],"Drug: paclitaxel","Drug: bevacizumab",{"label":30,"type":10,"description":21,"interventionNames":31},"GI-102 + eribulin",[32,13],"Drug: eribulin",{"label":34,"type":10,"description":21,"interventionNames":35},"GI-102 + trastuzumab deruxtecan (T-DXd)",[36,13],"Drug: trastuzumab deruxtecan (T-DXd)",{"label":38,"type":10,"description":21,"interventionNames":39},"GI-102 + pembrolizumab",[40,13],"Drug: pembrolizumab",[42,46,49,53,57,61,65,71,77],{"type":43,"name":15,"description":44,"armGroupLabels":45,"otherNames":21},"DRUG","0.12 mg\u002Fkg, 0.24 mg\u002Fkg or Recommended phase 2 dose of GI-102 will be administered via SC injection Q3W up to 2 years (approximately 35 years).",[15],{"type":43,"name":9,"description":47,"armGroupLabels":48,"otherNames":21},"Dose level will be escalated from 0.06 mg\u002Fkg to 0.45 mg\u002Fkg and Recommended phase 2 dose (or RP2D-1, RP2D+1) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).",[9],{"type":43,"name":50,"description":51,"armGroupLabels":52,"otherNames":21},"doxorubicin","Doxorubicin will be administered intravenously at a dose of 75 mg\u002Fm2 on Day 3 every 3-week (21-day) cycle for up to 6 cycles.",[20],{"type":43,"name":54,"description":55,"armGroupLabels":56,"otherNames":21},"paclitaxel","Paclitaxel will be administered intravenously over 1 hour at a dose of 80 mg\u002Fm2 each time weekly as a diluted solution according to the prescribing information.",[25],{"type":43,"name":58,"description":59,"armGroupLabels":60,"otherNames":21},"bevacizumab","Bevacizumab will be administered intravenously at a dose of 10 mg\u002Fkg every 2 weeks.",[25],{"type":43,"name":62,"description":63,"armGroupLabels":64,"otherNames":21},"eribulin","Eribulin will be administered intravenously at a dose of over 1.4 mg\u002Fm2 over 2 to 5 minutes on Days 3 and 10 every 3-week (21-day) cycle.",[30],{"type":43,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"trastuzumab deruxtecan (T-DXd)","T-DXd will be administered initially as a 5.4 mg\u002Fkg (or 6.4 mg\u002Fkg only for gastric cancer) IV over 30 - 90 minutes every 3 weeks.",[34],[70],"ENHERTU®",{"type":43,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"pembrolizumab","pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.",[38],[76],"KEYTRUDA®",{"type":43,"name":9,"description":78,"armGroupLabels":79,"otherNames":21},"Recommended phase 2 dose (or RP2D-1, RP2D-2) of GI-102 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).",[20,30,25,38,34],[81],{"name":82,"affiliation":5,"role":83},"Nari Yun, PhD","STUDY_DIRECTOR",[85,90],{"name":86,"role":87,"phone":88,"phoneExt":21,"email":89},"Jay Kim","CONTACT","+82-2-404-2003","Clinical-102@gi-innovation.com",{"name":91,"role":87,"phone":88,"phoneExt":21,"email":89},"Woosun Lee",[93,109,122,135,147,160,173,186,195,202,211],{"facility":94,"status":95,"city":96,"state":97,"zip":98,"country":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Mayo Clinic in Arizona","RECRUITING","Scottsdale","Arizona","85259","United States",{"type":101,"coordinates":102},"Point",[103,104],-111.89903,33.50921,{"lat":104,"lon":103},[107],{"name":108,"role":87,"phone":21,"phoneExt":21,"email":21},"Mahesh Seetharam, MD",{"facility":110,"status":95,"city":111,"state":112,"zip":113,"country":99,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Mayo Clinic in Florida","Jacksonville","Florida","32224",{"type":101,"coordinates":115},[116,117],-81.65565,30.33218,{"lat":117,"lon":116},[120],{"name":121,"role":87,"phone":21,"phoneExt":21,"email":21},"Yujie Zhao, MD, PhD",{"facility":123,"status":95,"city":124,"state":125,"zip":126,"country":99,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Mayo Clinic in Minnesota","Rochester","Minnesota","55905",{"type":101,"coordinates":128},[129,130],-92.4699,44.02163,{"lat":130,"lon":129},[133],{"name":134,"role":87,"phone":21,"phoneExt":21,"email":21},"Jian Li Campian, MD, PhD",{"facility":136,"status":95,"city":137,"state":137,"zip":138,"country":99,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Memorial Sloan-Kettering Cancer Center","New York","10065",{"type":101,"coordinates":140},[141,142],-74.00597,40.71427,{"lat":142,"lon":141},[145],{"name":146,"role":87,"phone":21,"phoneExt":21,"email":21},"Viswatej Avutu, MD",{"facility":148,"status":95,"city":149,"state":150,"zip":151,"country":99,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":101,"coordinates":153},[154,155],-81.69541,41.4995,{"lat":155,"lon":154},[158],{"name":159,"role":87,"phone":21,"phoneExt":21,"email":21},"Wen Wee Ma, MBBS",{"facility":161,"status":95,"city":162,"state":162,"zip":163,"country":164,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":101,"coordinates":166},[167,168],126.9784,37.566,{"lat":168,"lon":167},[171],{"name":172,"role":87,"phone":21,"phoneExt":21,"email":21},"Seock-Ah Im, MD, PhD",{"facility":174,"status":95,"city":175,"state":176,"zip":177,"country":164,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"St. Vincent's Hospital","Suwon","suwon","12647",{"type":101,"coordinates":179},[180,181],127.00889,37.29111,{"lat":181,"lon":180},[184],{"name":185,"role":87,"phone":21,"phoneExt":21,"email":21},"Byoung Yong Shim, MD, PhD",{"facility":187,"status":95,"city":162,"state":21,"zip":188,"country":164,"cosmosGeoPoint":189,"geoPoint":191,"contacts":192},"Yonsei University Health System, Severance Hospital","03722",{"type":101,"coordinates":190},[167,168],{"lat":168,"lon":167},[193],{"name":194,"role":87,"phone":21,"phoneExt":21,"email":21},"Byoung Chul Cho, MD, PhD",{"facility":187,"status":95,"city":162,"state":21,"zip":188,"country":164,"cosmosGeoPoint":196,"geoPoint":198,"contacts":199},{"type":101,"coordinates":197},[167,168],{"lat":168,"lon":167},[200],{"name":201,"role":87,"phone":21,"phoneExt":21,"email":21},"Jung-Yun Lee, MD, PhD",{"facility":203,"status":95,"city":162,"state":21,"zip":204,"country":164,"cosmosGeoPoint":205,"geoPoint":207,"contacts":208},"Asan Medical Center","05505",{"type":101,"coordinates":206},[167,168],{"lat":168,"lon":167},[209],{"name":210,"role":87,"phone":21,"phoneExt":21,"email":21},"Jae-Lyun Lee, MD, PhD",{"facility":212,"status":95,"city":162,"state":21,"zip":213,"country":164,"cosmosGeoPoint":214,"geoPoint":216,"contacts":217},"Samsung Medical Center","06351",{"type":101,"coordinates":215},[167,168],{"lat":168,"lon":167},[218],{"name":219,"role":87,"phone":21,"phoneExt":21,"email":21},"Seung Tae Kim, MD, PhD",{"type":221,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[223],{"name":224,"class":6},"Merck Sharp & Dohme LLC","100502647",false,"NCT05824975","A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)","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-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced or Metastatic Solid Tumors (KEYNOTE-G08)","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-102.\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-102.\n\nOther protocol defined inclusion exclusion criteria may apply","ALL","18 Years",{"count":234,"type":235},358,"ESTIMATED","INTERVENTIONAL",[238,239],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and\u002For metastatic solid tumors.",[242,243,244,245,246,247,248,249,250],"Advanced Solid Tumor","Metastatic Solid Tumor","Soft Tissue Sarcoma (STS)","Platinum-resistant Ovarian Cancer (PROC)","Hepatocellular Carcinoma (HCC)","Colorectal Cancer (CRC)","HER2 Negative Breast Cancer","Cutaneous Melanoma","Renal Cell Carcinoma (RCC)",[9,252,253,254,255,256,257,258,259,260,261,262,263,264,265,266],"CD80-IgG4 Fc-IL2 variant","Immunotherapy","IL-2","Interleukin-2","bispecific protein","immunocytokine","CD80","CTLA-4","Pembrolizumab","T-DXd","Trastuzumab deruxtecan","Doxorubicin","Paclitaxel","Bevacizumab","Eribulin","2024-11-21",{"date":269,"type":270},"2024-11-25","ACTUAL",{"date":272,"type":270},"2023-05-30",{"date":274,"type":235},"2027-04-24",{"name":5,"class":6},11]