[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607736":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":11,"armGroups":35,"interventions":44,"overallOfficials":11,"centralContacts":59,"locations":65,"responsibleParty":211,"collaborators":11,"id":213,"slug":11,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":214,"sex":220,"minAge":221,"maxAge":11,"enrollmentInfo":222,"targetDuration":11,"studyType":225,"phases":226,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},{"fullName":5,"class":6},"Vironexis Biotherapeutics Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)",null,"Change from Baseline to Year 5 post dosing",[14,17,19,21],{"measure":15,"description":11,"timeFrame":16},"Change from baseline in T cell subsets and clonality","Change from baseline to year 5 post dosing",{"measure":18,"description":11,"timeFrame":16},"Change from baseline in ctDNA",{"measure":20,"description":11,"timeFrame":16},"Change from baseline in progression free survival",{"measure":22,"description":11,"timeFrame":16},"Change from baseline in overall survival",[24,26],{"measure":25,"description":11,"timeFrame":16},"Change in VNX-202 gene product levels",{"measure":27,"description":11,"timeFrame":16},"Change in VNX-202 vector shedding",{"allocation":29,"interventionModel":30,"interventionModelDescription":11,"primaryPurpose":31,"observationalModel":11,"timePerspective":11,"maskingInfo":32},"NA","SEQUENTIAL","TREATMENT",{"masking":33,"maskingDescription":11,"whoMasked":11},"NONE","VNX-202 is an investigational adeno-associated virus (AAV) gene therapy developed to express a secreted anti-HER2\u002Fanti-CD3 scFv diabody (termed GP202). GP202 binds to human epidermal growth factor receptor 2 (HER2) on the surface of cancer cells and to cluster of differentiation (CD)3 on the surface of T cells, inducing the T cells to kill the HER2-positive cancer cells.\n\nFollowing a single intravenous (IV) infusion, the vector induces the liver to continuously secrete GP202 into the bloodstream, resulting in long-term, consistent serum levels of GP202. Compared with conventionally delivered protein therapies, this gene therapy approach obviates the requirement for episodic dosing and avoids a possible reduction or loss of efficacy associated with trough levels of the protein between treatment cycles.\n\nIn this 2-part study, dose-finding data from Part 1 of the study (n=\\~12 patients) will be used determine the dose for Part 2 in patients. Part 1 is a dose-finding PK study in adults ≥18 years old with previously treated metastatic HER2 solid tumors designed to determine the minimal dose that achieves target PK serum levels of GP202 at steady state (8-week timepoint) without dose-limited toxicities, defined as the recommended Part 2 dose (RP2D). Participants must have histologically or cytologically confirmed HER2 positive solid tumor cancers that has progressed during or following previous anti-cancer treatment. Part 2 (n=\\~15) will be opened following data safety monitoring board review of Part 1 data and is designed to determine the safety and pharmacokinetics (PK) of VNX-202 at the RP2D in a broader array of subjects. Part 2 will comprise of participants with early stage HER2-positive tumors who are at risk of disease relapse and\u002For metastasis despite having received prior systemic and\u002For local treatment. Each cohort will comprise ≥5 participants (Cohort A: breast cancer; Cohort B: gastric cancer; Cohort C: all otherHER2-positive tumor types). Patients will be followed for safety and efficacy up to 5 years post VNX-202 dosing.",[36],{"label":37,"type":38,"description":11,"interventionNames":39},"Group 1\u002FGroup 2\u002FGroup 3\u002FGroup 4","EXPERIMENTAL",[40,41,42,43],"Genetic: Dose Level 1, VNX-202","Genetic: Dose Level 2, VNX-202","Genetic: Dose Level 3, VNX-202","Genetic: Dose Level 4, VNX-202",[45,50,53,56],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":11},"GENETIC","Dose Level 1, VNX-202","Adeno-associated viral vector encoding the CD3\u002FHER2 Bi-Specific T-Cell Engager (AAV.CD3\u002FHER2), Single IV Infusion",[37],{"type":46,"name":51,"description":48,"armGroupLabels":52,"otherNames":11},"Dose Level 2, VNX-202",[37],{"type":46,"name":54,"description":48,"armGroupLabels":55,"otherNames":11},"Dose Level 3, VNX-202",[37],{"type":46,"name":57,"description":48,"armGroupLabels":58,"otherNames":11},"Dose Level 4, VNX-202",[37],[60],{"name":61,"role":62,"phone":63,"phoneExt":11,"email":64},"Allen Reha","CONTACT","908-938-6019","allen.reha@vironexis.com",[66,85,100,113,124,138,152,166,181,196],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Valkyrie Clinical Trials","RECRUITING","Los Angeles","California","90067","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-118.24368,34.05223,{"lat":78,"lon":77},[81],{"name":82,"role":62,"phone":83,"phoneExt":11,"email":84},"Myo Zaw","424-535-1874","clinicaltrials@vctcare.com",{"facility":86,"status":68,"city":87,"state":88,"zip":89,"country":72,"countryCode":73,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"SCRI Denver DDU at HealthOne","Denver","Colorado","80218",{"type":75,"coordinates":91},[92,93],-104.9847,39.73915,{"lat":93,"lon":92},[96],{"name":97,"role":62,"phone":98,"phoneExt":11,"email":99},"Julia Etchart","805-701-0185","julia.etchart@sarahcannon.com",{"facility":101,"status":68,"city":102,"state":103,"zip":104,"country":72,"countryCode":73,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Mayo Clinic","Jacksonville","Florida","32224",{"type":75,"coordinates":106},[107,108],-81.65565,30.33218,{"lat":108,"lon":107},[111],{"name":11,"role":62,"phone":112,"phoneExt":11,"email":11},"855-776-0015",{"facility":101,"status":68,"city":114,"state":115,"zip":116,"country":72,"countryCode":73,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Rochester","Minnesota","55095",{"type":75,"coordinates":118},[119,120],-92.4699,44.02163,{"lat":120,"lon":119},[123],{"name":11,"role":62,"phone":112,"phoneExt":11,"email":11},{"facility":125,"status":68,"city":126,"state":127,"zip":128,"country":72,"countryCode":73,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Hackensack Medical Center","Hackensack","New Jersey","07601",{"type":75,"coordinates":130},[131,132],-74.04347,40.88593,{"lat":132,"lon":131},[135],{"name":11,"role":62,"phone":136,"phoneExt":11,"email":137},"551-996-1777","OncologyResearchReferral@hmhn.org",{"facility":139,"status":68,"city":140,"state":140,"zip":141,"country":72,"countryCode":73,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"Memorial Sloan Kettering Cancer Center","New York","10065",{"type":75,"coordinates":143},[144,145],-74.00597,40.71427,{"lat":145,"lon":144},[148],{"name":149,"role":62,"phone":150,"phoneExt":11,"email":151},"Jamie Walters","917-843-7966","waltersj@mskcc.org",{"facility":153,"status":68,"city":154,"state":155,"zip":156,"country":72,"countryCode":73,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":75,"coordinates":158},[159,160],-81.69541,41.4995,{"lat":160,"lon":159},[163],{"name":11,"role":62,"phone":164,"phoneExt":11,"email":165},"866-223-8100","canceranswer@ccf.org",{"facility":167,"status":68,"city":168,"state":169,"zip":170,"country":72,"countryCode":73,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Thomas Jefferson University, Sidney Kimmel Cancer Center","Philadelphia","Pennsylvania","19107",{"type":75,"coordinates":172},[173,174],-75.16362,39.95238,{"lat":174,"lon":173},[177],{"name":178,"role":62,"phone":179,"phoneExt":11,"email":180},"Steven Manobianco, MD","215-955-8874","steven.manobianco@jefferson.edu",{"facility":182,"status":68,"city":183,"state":184,"zip":185,"country":72,"countryCode":73,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":75,"coordinates":187},[188,189],-86.78444,36.16589,{"lat":189,"lon":188},[192],{"name":193,"role":62,"phone":194,"phoneExt":11,"email":195},"SCRI Referrals","615-329-7274","SCRI.DDUreferrals@scri.com",{"facility":197,"status":68,"city":198,"state":199,"zip":200,"country":72,"countryCode":73,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"UT MD Anderson Cancer Center","Houston","Texas","77030",{"type":75,"coordinates":202},[203,204],-95.36327,29.76328,{"lat":204,"lon":203},[207],{"name":208,"role":62,"phone":209,"phoneExt":11,"email":210},"Christine Tran","713-794-1354","cmtran@mdanderson.org",{"type":212,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100607736",false,"NCT07192432","Gene Therapy for HER-Positive Cancer (SENTRY-HER2)","A Phase 1\u002F2, First-in-Human Study of VNX-202 Gene Therapy in Patients With HER2-Positive Cancer","SENTRY-HER2","Inclusion Criteria:\n\n* Age: ≥18 years of age\n* Histologically or cytologically confirmed diagnosis of HER-2 positive solid tumor as defined in the protocol\n* Part 1: presence of advanced or metastatic disease that has progressed during or following previous treatment\n* Part 2: Early stage HER-2 positive cancers with high risk for relapse following completion of SOC or after neoadjuvant systemic treatment\n* AAV specified capsid total antibody ≤1:400\n* ECOG performance status of 0 or 1\n* Life expectancy ≥3 months\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* Known active CNS or leptomeningeal disease\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* History of other malignancy within 5 years prior to screening as defined in protocol\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity Concurrent anti-cancer treatment in another investigational trial","ALL","18 Years",{"count":223,"type":224},27,"ESTIMATED","INTERVENTIONAL",[227,228],"PHASE1","PHASE2","This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.",[231],"HER2 Expressing Solid Tumors",[233,234,235,236],"HER2+ breast cancer","HER2+ gastric cancer","Other HER+ cancer","HER2-low cancer","2026-06-22",{"date":239,"type":240},"2026-06-24","ACTUAL",{"date":242,"type":240},"2025-11-18",{"date":244,"type":224},"2033-10",{"name":5,"class":6},10]