[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100534466":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":129,"collaborators":32,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":32,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":32,"enrollmentInfo":140,"targetDuration":32,"studyType":143,"phases":144,"briefSummary":147,"conditions":148,"keywords":32,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},{"fullName":5,"class":6},"ModeX Therapeutics, An OPKO Health Company","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a - MDX2001 Dose Escalation","EXPERIMENTAL","Patients with metastatic solid tumors will receive MDX2001 as intravenous (IV) infusion.",[13],"Drug: MDX2001",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1b - Indication Optimization","Patients with a single tumor indication receive MDX2001 as intravenous (IV) infusion.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Phase 1b - Dose Optimization","Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Phase 2a - Cohort Expansion","Patients with a single tumor indication will receive MDX2001 as intravenous (IV) infusion at the recommended Phase 2 dose.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","MDX2001","MDX2001 intravenous infusion",[9,19,15,23],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Email recommended","CONTACT","(857) 233-9936","info@modextx.com",[40,61,75,89,102,116],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Sarah Cannon Research Institute","RECRUITING","Denver","Colorado","80218","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-104.9847,39.73915,{"lat":52,"lon":51},[55,58],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":38},"ModeX Therapeutics","+1 857-233-9936",{"name":59,"role":60,"phone":32,"phoneExt":32,"email":32},"Gerald Falchook, MD","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":42,"city":63,"state":64,"zip":65,"country":46,"countryCode":47,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Sylvester Comprehensive Cancer Center - University of Miami Health System","Miami","Florida","33136",{"type":49,"coordinates":67},[68,69],-80.19366,25.77427,{"lat":69,"lon":68},[72,73],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":38},{"name":74,"role":60,"phone":32,"phoneExt":32,"email":32},"Jaime Merchan, MD",{"facility":76,"status":42,"city":77,"state":78,"zip":79,"country":46,"countryCode":47,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":49,"coordinates":81},[82,83],-71.05977,42.35843,{"lat":83,"lon":82},[86,87],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":38},{"name":88,"role":60,"phone":32,"phoneExt":32,"email":32},"Rebecca Heist, MD, MPH",{"facility":41,"status":42,"city":90,"state":91,"zip":92,"country":46,"countryCode":47,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Nashville","Tennessee","37203",{"type":49,"coordinates":94},[95,96],-86.78444,36.16589,{"lat":96,"lon":95},[99,100],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":38},{"name":101,"role":60,"phone":32,"phoneExt":32,"email":32},"Melissa Johnson, MD",{"facility":103,"status":42,"city":104,"state":105,"zip":106,"country":46,"countryCode":47,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"MD Anderson Cancer Center","Houston","Texas","77030",{"type":49,"coordinates":108},[109,110],-95.36327,29.76328,{"lat":110,"lon":109},[113,114],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":38},{"name":115,"role":60,"phone":32,"phoneExt":32,"email":32},"Ecaterina Dumbrava, MD",{"facility":117,"status":42,"city":118,"state":105,"zip":119,"country":46,"countryCode":47,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"NEXT Oncology","San Antonio","78229",{"type":49,"coordinates":121},[122,123],-98.49363,29.42412,{"lat":123,"lon":122},[126,127],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":38},{"name":128,"role":60,"phone":32,"phoneExt":32,"email":32},"David Sommerhalder, MD",{"type":130,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100534466","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2001-in-patients-with-advanced-solid-tumors-100534466",false,"NCT06239194","Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors","A Phase 1\u002F2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Histologically or cytologically confirmed diagnosis of metastatic solid tumors\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.\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* Adequate hematologic, hepatic and renal function\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* Prior solid organ or hematologic transplant\n* Known untreated, active, or uncontrolled brain metastases\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment.\n* Receipt of a live-virus vaccination within 28 days of planned treatment start\n* Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.\n* Participation in a concurrent clinical study in the treatment period.\n* Known hypersensitivity to MDX2001 or any of its ingredients\n* Supplemental oxygen use for activities of daily living\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.","ALL","18 Years",{"count":141,"type":142},285,"ESTIMATED","INTERVENTIONAL",[145,146],"PHASE1","PHASE2","This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.",[149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164],"Biliary Tract Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gastric Cancer","GastroEsophageal Cancer","Head and Neck Cancer","Hepatocellular Cancer","Non-small Cell Lung Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Renal Cancer","Thyroid Cancer","2026-05-03",{"date":167,"type":168},"2026-05-06","ACTUAL",{"date":170,"type":168},"2024-06-12",{"date":172,"type":142},"2029-02",{"name":5,"class":6},6]