[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ModeX Therapeutics, An OPKO Health Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":130},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,81,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100627233","phase-1-a-study-evaluating-mdx2301-in-healthy-adults-and-adults-at-higher-risk-for-severe-covid-19-100627233",false,"NCT07445971","A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.","A Phase 1a\u002Fb Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19","Inclusion Criteria\n\nHealthy Adults\n\n1. Participant is a healthy male or female, 18 to 64 years of age.\n2. Participant is in good health in the opinion of the investigator.\n\n   Adults at Higher Risk for Developing Severe COVID-19:\n3. Participant is a male or female, 18 to 64 years of age.\n4. Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors:\n\n   1. Asthma\n   2. Diabetes\n   3. Cerebrovascular disease, which affects blood flow to the brain.\n   4. Chronic kidney disease\n   5. Chronic lung disease\n   6. Cardiac disease\n   7. Chronic liver disease\n   8. Cystic fibrosis\n   9. HIV clinically stable on antiretroviral therapy for at least 6 months prior to screening.\n   10. Sickle cell disease or thalassemia\n5. Participant is clinically stable with no clinically significant abnormalities.\n6. Participant has not been hospitalized within the 12 months prior to screening or is not expected to be hospitalized during the study due to underlying medical conditions.\n\n   All Participants\n7. Female participants of childbearing potential must have a negative urine pregnancy test.\n8. Female participants of childbearing potential must agree to follow instructions for a highly effective birth control method.\n9. Participant is able to understand and sign the informed consent form prior to undergoing any study procedures.\n10. Participant is willing and able to comply with scheduled visits and procedures.\n\nExclusion Criteria:\n\nHealthy Adults\n\n1. Participant has any chronic or significant medical condition that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug.\n2. Participant has evidence of active HIV, hepatitis B, or hepatitis C infections at screening.\n\n   Adults at Higher Risk for Severe COVID-19:\n3. Participant has any serious disease, condition, or disorder that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug or interpretation of study results, or may lead to hospitalization or death within the study period.\n4. Participant has evidence of active hepatitis B or hepatitis C infections at screening.\n\n   All Participants\n5. Participant has abnormal vital signs, ECG findings, or laboratory values at Screening or Day -1.\n6. Participant tests positive for SARS-CoV-2 infection at screening.\n7. Participant self-reports having COVID-19 or received COVID-19 antiviral for prophylaxis or treatment prior to Day 1.\n8. Participant has received a SARS-CoV-2 vaccine prior to dosing.\n9. Participant has received a monoclonal antibody (mAb) for SARS-CoV-2 or convalescent plasma for SARS-CoV-2 prior to Day 1.\n10. Participant has received or is expected to receive for the duration of the study immunoglobulin, blood-derived products, high-dose systemic corticosteroids, or other immunosuppressant drugs within 6 months prior to Day 1.\n11. Participant is pregnant, breastfeeding, or seeking pregnancy while on the study.\n12. Participant with a known clinically significant bleeding disorder that would prohibit the participant from receiving an IV infusion or IM or SC injection.\n13. Participant had major surgery within 30 days prior to Day 1.\n14. Participant has donated blood prior to screening.\n15. Participant has any skin condition and\u002For tattoo that may interfere with the evaluation of safety at the injection site.\n16. Participant has a history of alcoholism or illicit drug use prior to screening or a positive test for drugs of abuse at screening or on Day -1.\n17. Participant is a current smoker or user of other nicotine containing products on a daily basis.\n18. Participant has received an investigational product within 30 days prior to Day 1.\n19. Participant has a known hypersensitivity to any components of MDX2301, any of its excipients or closely related compounds.\n\n    For All Participants, Temporary Exclusions for Randomization on Day 1 if Remains within the Screening Window:\n20. Participant has any acute illness, within 3 days of Day 1.\n21. Participant has vital signs considered by the investigator to be clinically significant prior to study drug administration.\n22. Participant has had close contact with anyone confirmed to have SARS-CoV-2 infection within the 7 days prior to Day 1.\n23. Any acute drug therapy prescribed by a physician within 7 days prior to Day 1.",true,"ALL","18 Years","64 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, anti-drug antibodies, and neutralizing activity of MDX2301 administered by intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes in healthy adults and adults at higher risk for severe COVID-19. Participants will receive single IV, IM, and SC doses of MDX2301 or placebo and a repeat IM or SC dose approximately 3 months apart of MDX2301 or placebo.",[28,29],"COVID -19","COVID-19 (Prevention)","RECRUITING","2026-05-15",{"date":33,"type":34},"2026-05-18","ACTUAL",{"date":36,"type":34},"2026-03-24",{"date":38,"type":22},"2027-12",{"name":40,"class":41},"ModeX Therapeutics, An OPKO Health Company","INDUSTRY",2,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100534466","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2001-in-patients-with-advanced-solid-tumors-100534466","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.",{"count":51,"type":22},285,[25,53],"PHASE2","This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.",[56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71],"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":74,"type":34},"2026-05-06",{"date":76,"type":34},"2024-06-12",{"date":78,"type":22},"2029-02",{"name":40,"class":41},6,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":42},"100612155","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2003-in-patients-with-different-types-of-lymphoma-100612155","NCT07249905","Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma","A Phase 1\u002F2 Clinical Study Evaluating MDX2003 in Participants With Relapsed, Progressive, or Refractory B-Cell Malignancies","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Participant has a confirmed diagnosis of large B-cell lymphoma (including DLBCL, high-grade B-cell lymphoma \\[HGBCL\\], primary mediastinal B-cell lymphoma \\[PMBCL\\], etc), FL, MCL, marginal zone lymphoma, transformation of indolent B-cell lymphoma, or lymphoplasmacytic lymphoma, including Waldenstrom macroglobulinemia.\n* Participant has relapsed or progressed on at least 2 prior lines of therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* All participants must have measurable disease via computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT.\n* Documented CD19 or CD20 positivity of their B-cell neoplasm based on any representative pathology report from the past 3 months.\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* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Unresolved toxicities from previous anticancer therapy.\n* Primary central nervous system (CNS) lymphoma or known CNS involvement with lymphoma.\n* Active medical condition requiring chronic systemic steroid use (\\>10 mg\u002Fday prednisone or equivalent of \\>140 mg over the last 14 days) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2003.\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.\n* Participant has a history of allogenic tissue or solid organ transplant, with the exception of corneal transplants.\n* Known hypersensitivity to allopurinol or rasburicase.\n* Participant has a seizure disorder requiring therapy at the time of screening (such as steroids or anti-epileptics).\n* Participant is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.",{"count":89,"type":22},180,[25,53],"This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2003 in patients with different types of lymphoma",[93,94,95,96,97,98,99,100],"Lymphoma","Waldenström Macroglobulinemia (WM)","DLBCL - Diffuse Large B Cell Lymphoma","PMBCL","HGBCL","FL Lymphoma","Lymphoplasmacytic Lymphoma","Follicular Lymphoma (FL)","2026-04-30",{"date":103,"type":34},"2026-05-04",{"date":105,"type":34},"2026-04-13",{"date":107,"type":22},"2030-04",{"name":40,"class":41},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":4,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":80},"100601445","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2004-in-participants-with-advanced-tumors-100601445","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.",{"count":117,"type":22},235,[25,53],"This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.",[121],"Advanced Tumors","2026-03-04",{"date":124,"type":34},"2026-03-05",{"date":126,"type":34},"2025-10-01",{"date":128,"type":22},"2031-06-30",{"name":40,"class":41},""]