[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601445":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":38,"responsibleParty":126,"collaborators":32,"id":128,"slug":32,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":32,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":32,"enrollmentInfo":136,"targetDuration":32,"studyType":139,"phases":140,"briefSummary":143,"conditions":144,"keywords":32,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"ModeX Therapeutics, An OPKO Health Company","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation - Part A","EXPERIMENTAL","Participants with advanced tumors will receive MDX2004 as intravenous (IV) infusion.",[13],"Drug: MDX2004",{"label":15,"type":10,"description":16,"interventionNames":17},"Indication Optimization - Part B","Participants with select advanced tumors will receive MDX2004 as intravenous (IV) infusion.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dose Optimization - Part C","Participants with select advanced tumors will receive one of two recommended doses of MDX2004 as intravenous (IV) infusion.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Dose Expansion - Part D","Participants with select advanced tumors will receive the recommended Phase 2 dose of MDX2004 as intravenous (IV) infusion.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","MDX2004","MDX2004 intravenous infusion",[9,23,19,15],null,[34],{"name":5,"role":35,"phone":36,"phoneExt":32,"email":37},"CONTACT","+1 857-233-9936","info@modextx.com",[39,58,72,86,100,113],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Liverpool Hospital","RECRUITING","Liverpool","New South Wales","2170","Australia",{"type":47,"coordinates":48},"Point",[49,50],150.92588,-33.91938,{"lat":50,"lon":49},[53,55],{"name":54,"role":35,"phone":36,"phoneExt":32,"email":37},"Modex Therapeutics",{"name":56,"role":57,"phone":32,"phoneExt":32,"email":32},"Udit Nindra, MD","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":41,"city":60,"state":43,"zip":61,"country":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Calvary Mater Newcastle","Waratah","2298",{"type":47,"coordinates":63},[64,65],151.72647,-32.90667,{"lat":65,"lon":64},[68,70],{"name":69,"role":35,"phone":36,"phoneExt":32,"email":37},"ModeX Therapeutics",{"name":71,"role":57,"phone":32,"phoneExt":32,"email":32},"Jordan Cohen, MD",{"facility":73,"status":41,"city":74,"state":75,"zip":76,"country":45,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Princess Alexandra Hospital","Woolloongabba","Queensland","4102",{"type":47,"coordinates":78},[79,80],153.03655,-27.48855,{"lat":80,"lon":79},[83,84],{"name":69,"role":35,"phone":36,"phoneExt":32,"email":37},{"name":85,"role":57,"phone":32,"phoneExt":32,"email":32},"Ken O'Byrne, MD",{"facility":87,"status":41,"city":88,"state":32,"zip":89,"country":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Rambam Health Care Campus","Haifa","3109601","Israel",{"type":47,"coordinates":92},[93,94],34.99928,32.81303,{"lat":94,"lon":93},[97,98],{"name":69,"role":35,"phone":36,"phoneExt":32,"email":37},{"name":99,"role":57,"phone":32,"phoneExt":32,"email":32},"Ruth Perets, MD",{"facility":101,"status":41,"city":102,"state":32,"zip":103,"country":90,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Hadassah University Hospital-Ein Kerem","Jerusalem","9574409",{"type":47,"coordinates":105},[106,107],35.21633,31.76904,{"lat":107,"lon":106},[110,111],{"name":32,"role":35,"phone":36,"phoneExt":32,"email":37},{"name":112,"role":57,"phone":32,"phoneExt":32,"email":32},"Yakir Rottenberg, MD",{"facility":114,"status":41,"city":115,"state":32,"zip":116,"country":90,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Tel Aviv Sourasky Medical Center","Tel Aviv","6423906",{"type":47,"coordinates":118},[119,120],34.78057,32.08088,{"lat":120,"lon":119},[123,124],{"name":69,"role":35,"phone":36,"phoneExt":32,"email":37},{"name":125,"role":57,"phone":32,"phoneExt":32,"email":32},"Ravit Geva, MD",{"type":127,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100601445",false,"NCT07110584","Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors","A Phase 1\u002F2, Multi-Center, Open-Label Clinical Study Evaluating MDX2004 In Participants With Advanced Tumors","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic malignancy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* All participants should have at least 1 measurable site of disease according to RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.\n* Adequate hematologic, hepatic and renal function.\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease.\n* Unresolved toxicities from previous anticancer therapy.\n* Known untreated, active, or uncontrolled brain metastases.\n* Previous Grade 3 or 4 immune-related toxicity that led to the discontinuation of treatment, within 6 months prior to the first dose of MDX2004.\n* Active medical condition requiring chronic systemic steroid use (\\>10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2004.\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.\n* Prior solid organ or hematologic transplant\n* Require supplemental oxygen for activities of daily living\n* Participant is not suitable for participation, whatever the reason, as judged by the Investigator including medical or clinical conditions.","ALL","18 Years",{"count":137,"type":138},235,"ESTIMATED","INTERVENTIONAL",[141,142],"PHASE1","PHASE2","This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.",[145],"Advanced Tumors","2026-03-04",{"date":148,"type":149},"2026-03-05","ACTUAL",{"date":151,"type":149},"2025-10-01",{"date":153,"type":138},"2031-06-30",{"name":5,"class":6},6]