[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601445":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":38,"responsibleParty":128,"collaborators":32,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":32,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":32,"enrollmentInfo":139,"targetDuration":32,"studyType":142,"phases":143,"briefSummary":146,"conditions":147,"keywords":32,"overallStatus":41,"whyStopped":32,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"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",[39,59,73,87,102,115],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Liverpool Hospital","RECRUITING","Liverpool","New South Wales","2170","Australia","AU",{"type":48,"coordinates":49},"Point",[50,51],150.92588,-33.91938,{"lat":51,"lon":50},[54,56],{"name":55,"role":35,"phone":36,"phoneExt":32,"email":37},"Modex Therapeutics",{"name":57,"role":58,"phone":32,"phoneExt":32,"email":32},"Udit Nindra, MD","PRINCIPAL_INVESTIGATOR",{"facility":60,"status":41,"city":61,"state":43,"zip":62,"country":45,"countryCode":46,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Calvary Mater Newcastle","Waratah","2298",{"type":48,"coordinates":64},[65,66],151.72647,-32.90667,{"lat":66,"lon":65},[69,71],{"name":70,"role":35,"phone":36,"phoneExt":32,"email":37},"ModeX Therapeutics",{"name":72,"role":58,"phone":32,"phoneExt":32,"email":32},"Jordan Cohen, MD",{"facility":74,"status":41,"city":75,"state":76,"zip":77,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Princess Alexandra Hospital","Woolloongabba","Queensland","4102",{"type":48,"coordinates":79},[80,81],153.03655,-27.48855,{"lat":81,"lon":80},[84,85],{"name":70,"role":35,"phone":36,"phoneExt":32,"email":37},{"name":86,"role":58,"phone":32,"phoneExt":32,"email":32},"Ken O'Byrne, MD",{"facility":88,"status":41,"city":89,"state":32,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Rambam Health Care Campus","Haifa","3109601","Israel","IL",{"type":48,"coordinates":94},[95,96],34.99928,32.81303,{"lat":96,"lon":95},[99,100],{"name":70,"role":35,"phone":36,"phoneExt":32,"email":37},{"name":101,"role":58,"phone":32,"phoneExt":32,"email":32},"Ruth Perets, MD",{"facility":103,"status":41,"city":104,"state":32,"zip":105,"country":91,"countryCode":92,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Hadassah University Hospital-Ein Kerem","Jerusalem","9574409",{"type":48,"coordinates":107},[108,109],35.21633,31.76904,{"lat":109,"lon":108},[112,113],{"name":32,"role":35,"phone":36,"phoneExt":32,"email":37},{"name":114,"role":58,"phone":32,"phoneExt":32,"email":32},"Yakir Rottenberg, MD",{"facility":116,"status":41,"city":117,"state":32,"zip":118,"country":91,"countryCode":92,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Tel Aviv Sourasky Medical Center","Tel Aviv","6423906",{"type":48,"coordinates":120},[121,122],34.78057,32.08088,{"lat":122,"lon":121},[125,126],{"name":70,"role":35,"phone":36,"phoneExt":32,"email":37},{"name":127,"role":58,"phone":32,"phoneExt":32,"email":32},"Ravit Geva, MD",{"type":129,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100601445","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2004-in-participants-with-advanced-tumors-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":140,"type":141},235,"ESTIMATED","INTERVENTIONAL",[144,145],"PHASE1","PHASE2","This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.",[148],"Advanced Tumors","2026-03-04",{"date":151,"type":152},"2026-03-05","ACTUAL",{"date":154,"type":152},"2025-10-01",{"date":156,"type":141},"2031-06-30",{"name":5,"class":6},6]