[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546346":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":199,"collaborators":33,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":33,"eligibilityCriteria":207,"healthyVolunteers":203,"sex":208,"minAge":209,"maxAge":33,"enrollmentInfo":210,"targetDuration":33,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":220,"overallStatus":47,"whyStopped":33,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":237},{"fullName":5,"class":6},"Arvinas Inc.","INDUSTRY",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A Monotherapy Dose escalation","EXPERIMENTAL","Participants with R\u002FR NHL will receive ARV-393 dose escalation beginning at dose level 1",[13],"Drug: ARV-393",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B Monotherapy: Dose expansion\u002Foptimization","Dose expansion and optimization of ARV-393 will be conducted in Part B to determine the recommended phase 2 dose (RP2D) for participants with R\u002FR NHL",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part C Combination therapy: Dose escalation","Participants with R\u002FR diffuse large B-cell lymphoma (DLBCL) will receive ARV-393 in combination with glofitamab, beginning at an ARV-393 dose informed by the Part A. Glofitamab will be given per labelled prescribing information. Part C will be conducted in non-USA centers.",[13,22],"Drug: Glofitamab",{"label":24,"type":10,"description":25,"interventionNames":26},"Part D Combination therapy: Dose expansion\u002Foptimization","Part D will be an optimization of ARV-393 in combination with glofitamab to determine a potential RP2D for ARV-393 in the combination regimen. Part D will be conducted in non-USA centers in participants with R\u002FR DLBCL.",[13,22],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","ARV-393","Oral daily dose of ARV-393 at a specified dose level",[9,15,19,24],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Glofitamab","Glofitamab infusion per labelled prescribing information",[19,24],[39],{"name":40,"role":41,"phone":42,"phoneExt":33,"email":43},"Arvinas Operations, Inc.","CONTACT","475-345-0791","clinicaltrialsARV-393@arvinas.com",[45,59,68,77,85,90,99,108,117,128,137,147,155,166,175,183,191],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":33},"Clinical Trial Site","RECRUITING","New Haven","Connecticut","06510","United 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Palmar","Murcia","30120","Spain","ES",{"type":54,"coordinates":162},[163,164],-1.16095,37.93939,{"lat":164,"lon":163},{"facility":46,"status":47,"city":167,"state":168,"zip":169,"country":159,"countryCode":160,"cosmosGeoPoint":170,"geoPoint":174,"contacts":33},"Pamplona","Navarre","31008",{"type":54,"coordinates":171},[172,173],-1.64323,42.81687,{"lat":173,"lon":172},{"facility":46,"status":47,"city":176,"state":33,"zip":177,"country":159,"countryCode":160,"cosmosGeoPoint":178,"geoPoint":182,"contacts":33},"Barcelona","8908",{"type":54,"coordinates":179},[180,181],2.15899,41.38879,{"lat":181,"lon":180},{"facility":46,"status":47,"city":184,"state":33,"zip":185,"country":159,"countryCode":160,"cosmosGeoPoint":186,"geoPoint":190,"contacts":33},"Madrid","28050",{"type":54,"coordinates":187},[188,189],-3.70256,40.4165,{"lat":189,"lon":188},{"facility":46,"status":47,"city":192,"state":33,"zip":193,"country":159,"countryCode":160,"cosmosGeoPoint":194,"geoPoint":198,"contacts":33},"Salamanca","37007",{"type":54,"coordinates":195},[196,197],-5.66388,40.96882,{"lat":197,"lon":196},{"type":200,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100546346","phase-1-a-study-of-arv-393-in-relapsedrefractory-non-hodgkin-lymphoma-100546346",false,"NCT06393738","A Study of ARV-393 in Relapsed\u002FRefractory Non-Hodgkin Lymphoma.","A Phase 1 First in Human Study of ARV-393 in Adult Participants With Advanced Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\n* For Part A and B: Have relapsed\u002Frefractory NHL and \\>=2 prior systemic therapies, (including rituximab), and be ineligible for known therapies with demonstrated clinical benefit per investigator assessment or, histologically confirmed AITL that has recurred or progressed following institutional standard of care therapy.\n* For Part C and D: Have R\u002FR DLBCL, not otherwise specified \\[NOS (DLBCL, NOS)\\] or large B-cell lymphoma (LBCL) arising from follicular lymphoma and have received two or more lines of systemic therapy.\n* Have at least one bi dimensionally measurable lesion \\>1.5-centimeter (cm) in largest dimension for nodal or \\>1.0 cm for extranodal lesion.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (NOTE: For Part A only - ECOG PS of 2 is allowed for participants with secondary CNS lymphoma).\n* Adequate bone marrow function\n* Adequate kidney function\n* Adequate Liver Function\n\nExclusion Criteria:\n\n* Current or past history of peripheral eosinophilia, hypereosinophilic syndrome (HES), organ-specific eosinophilic disorder, or drug reaction with eosinophilia and systemic symptoms (DRESS).\n* Prior allogeneic stem cell transplant (SCT) or solid organ transplantation.\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, melanoma in situ or carcinoma in situ of the breast or cervix, and prostate cancer with active surveillance.\n* Any of the following in the previous 6 months:\n\n  * Myocardial infarction, long QT syndrome or family history of long QT syndrome, or Torsade de Pointes;\n  * Clinically important atrial or ventricular arrhythmias;\n  * Serious conduction system abnormalities, 3rd degree atrioventricular (AV block), unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (CHF), New York Heart Association Class III or IV;\n  * Cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and\u002For other clinically significant episode of thromboembolic disease;\n* Active inflammatory gastrointestinal (GI) disease, chronic diarrhea, previous gastric resection, or lap band surgery.\n* Uncontrolled hypertension despite optimal medical treatment\n* History of myocarditis.\n* In ability to comply with listed prohibited treatments.\n* Standard 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.\n* Cardiac ejection fraction \\\u003C45%.","ALL","18 Years",{"count":211,"type":212},255,"ESTIMATED","INTERVENTIONAL",[215],"PHASE1","This clinical trial is studying the safety and potential anti-tumor activity of an investigational drug called ARV-393 in patients diagnosed with advanced Relapsed\u002FRefractory non-Hodgkin's lymphoma (R\u002FR NHL) to determine if ARV-393 may be a possible treatment option.\n\nARV-393 is thought to work by breaking down a protein present in many types of non-Hodgkins lymphomas, which may prevent, slow or stop tumor growth. This is the first time ARV-393 will be used by people. The investigational drug will be given as an oral tablet.",[218,219],"Relapsed\u002FRefractory (R\u002FR) Mature B Cell Non Hodgkin Lymphoma (NHL)","Relapsed\u002FRefractory (R\u002FR) Angioimmunoblastic T-cell Lymphoma (AITL)",[221,222,223,224,225,226,227],"Relapsed\u002FRefractory B cell Non Hodgkin Lymphoma (NHL)","Relapsed\u002FRefractory Angioimmunoblastic T-cell lymphoma (AITL)","Advanced non-Hodgkin Lymphoma","advanced NHL","relapsed non-Hodgkin Lymphoma","refractory non-Hodgkin Lymphoma","B Cell Advanced Non-Hodgkin Lymphoma","2026-02-06",{"date":230,"type":231},"2026-02-10","ACTUAL",{"date":233,"type":231},"2024-09-05",{"date":235,"type":212},"2028-03",{"name":5,"class":6},17]