[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502647":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":80,"centralContacts":84,"locations":92,"responsibleParty":221,"collaborators":223,"id":226,"slug":21,"hasResults":227,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":21,"eligibilityCriteria":231,"healthyVolunteers":227,"sex":232,"minAge":233,"maxAge":21,"enrollmentInfo":234,"targetDuration":21,"studyType":237,"phases":238,"briefSummary":241,"conditions":242,"keywords":252,"overallStatus":95,"whyStopped":21,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},{"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",[93,110,123,136,148,161,174,187,196,203,212],{"facility":94,"status":95,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":107},"Mayo Clinic in Arizona","RECRUITING","Scottsdale","Arizona","85259","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-111.89903,33.50921,{"lat":105,"lon":104},[108],{"name":109,"role":87,"phone":21,"phoneExt":21,"email":21},"Mahesh Seetharam, MD",{"facility":111,"status":95,"city":112,"state":113,"zip":114,"country":99,"countryCode":100,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Mayo Clinic in Florida","Jacksonville","Florida","32224",{"type":102,"coordinates":116},[117,118],-81.65565,30.33218,{"lat":118,"lon":117},[121],{"name":122,"role":87,"phone":21,"phoneExt":21,"email":21},"Yujie Zhao, MD, PhD",{"facility":124,"status":95,"city":125,"state":126,"zip":127,"country":99,"countryCode":100,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Mayo Clinic in Minnesota","Rochester","Minnesota","55905",{"type":102,"coordinates":129},[130,131],-92.4699,44.02163,{"lat":131,"lon":130},[134],{"name":135,"role":87,"phone":21,"phoneExt":21,"email":21},"Jian Li Campian, MD, PhD",{"facility":137,"status":95,"city":138,"state":138,"zip":139,"country":99,"countryCode":100,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Memorial Sloan-Kettering Cancer Center","New York","10065",{"type":102,"coordinates":141},[142,143],-74.00597,40.71427,{"lat":143,"lon":142},[146],{"name":147,"role":87,"phone":21,"phoneExt":21,"email":21},"Viswatej Avutu, MD",{"facility":149,"status":95,"city":150,"state":151,"zip":152,"country":99,"countryCode":100,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":102,"coordinates":154},[155,156],-81.69541,41.4995,{"lat":156,"lon":155},[159],{"name":160,"role":87,"phone":21,"phoneExt":21,"email":21},"Wen Wee Ma, MBBS",{"facility":162,"status":95,"city":163,"state":163,"zip":164,"country":165,"countryCode":21,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":102,"coordinates":167},[168,169],126.9784,37.566,{"lat":169,"lon":168},[172],{"name":173,"role":87,"phone":21,"phoneExt":21,"email":21},"Seock-Ah Im, MD, PhD",{"facility":175,"status":95,"city":176,"state":177,"zip":178,"country":165,"countryCode":21,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"St. Vincent's Hospital","Suwon","suwon","12647",{"type":102,"coordinates":180},[181,182],127.00889,37.29111,{"lat":182,"lon":181},[185],{"name":186,"role":87,"phone":21,"phoneExt":21,"email":21},"Byoung Yong Shim, MD, PhD",{"facility":188,"status":95,"city":163,"state":21,"zip":189,"country":165,"countryCode":21,"cosmosGeoPoint":190,"geoPoint":192,"contacts":193},"Yonsei University Health System, Severance Hospital","03722",{"type":102,"coordinates":191},[168,169],{"lat":169,"lon":168},[194],{"name":195,"role":87,"phone":21,"phoneExt":21,"email":21},"Byoung Chul Cho, MD, PhD",{"facility":188,"status":95,"city":163,"state":21,"zip":189,"country":165,"countryCode":21,"cosmosGeoPoint":197,"geoPoint":199,"contacts":200},{"type":102,"coordinates":198},[168,169],{"lat":169,"lon":168},[201],{"name":202,"role":87,"phone":21,"phoneExt":21,"email":21},"Jung-Yun Lee, MD, PhD",{"facility":204,"status":95,"city":163,"state":21,"zip":205,"country":165,"countryCode":21,"cosmosGeoPoint":206,"geoPoint":208,"contacts":209},"Asan Medical Center","05505",{"type":102,"coordinates":207},[168,169],{"lat":169,"lon":168},[210],{"name":211,"role":87,"phone":21,"phoneExt":21,"email":21},"Jae-Lyun Lee, MD, PhD",{"facility":213,"status":95,"city":163,"state":21,"zip":214,"country":165,"countryCode":21,"cosmosGeoPoint":215,"geoPoint":217,"contacts":218},"Samsung Medical Center","06351",{"type":102,"coordinates":216},[168,169],{"lat":169,"lon":168},[219],{"name":220,"role":87,"phone":21,"phoneExt":21,"email":21},"Seung Tae Kim, MD, PhD",{"type":222,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[224],{"name":225,"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":235,"type":236},358,"ESTIMATED","INTERVENTIONAL",[239,240],"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.",[243,244,245,246,247,248,249,250,251],"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)",[9,253,254,255,256,257,258,259,260,261,262,263,264,265,266,267],"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":270,"type":271},"2024-11-25","ACTUAL",{"date":273,"type":271},"2023-05-30",{"date":275,"type":236},"2027-04-24",{"name":5,"class":6},11]