[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-expressing-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-expressing-solid-tumors":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100607736","phase-1-gene-therapy-for-her-positive-cancer-sentry-her2-100607736",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":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24,25],"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.",[28],"HER2 Expressing Solid Tumors",[30,31,32,33],"HER2+ breast cancer","HER2+ gastric cancer","Other HER+ cancer","HER2-low cancer","RECRUITING","2026-06-22",{"date":37,"type":38},"2026-06-24","ACTUAL",{"date":40,"type":38},"2025-11-18",{"date":42,"type":21},"2033-10",{"name":44,"class":45},"Vironexis Biotherapeutics Inc.","INDUSTRY",10,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100618630","phase-1-safety-pharmacokinetics-pharmacodynamics-and-preliminary-efficacy-of-mt-304-in-adults-with-advanced-her2-expressing-solid-tumors-100618630","NCT07334119","Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors","A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors","Inclusion Criteria:\n\n* Aged 18 years or above\n* Histologically confirmed diagnosis of metastatic or advanced epithelial cancer expressing HER2 (Note: Participants with other tumor types expressing HER2 may be considered pending discussion with the Medical Monitor).\n* Measurable lesion per RECIST 1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1.\n* Adequate Organ function\n\nExclusion Criteria:\n\n* Known active CNS metastasis and\u002For carcinomatous meningitis.\n* Any acute illness including fever.\n* History of symptomatic congestive heart failure\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites\n* Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.",{"count":55,"type":21},60,[24],"This clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-304 in adults with advanced HER2-expressing solid tumors. The main questions it aims to answer are:\n\n* What is the safety profile of MT-304 when administered alone or with nivolumab?\n* What is the recommended Phase 2 dose (RP2D) of MT-304?\n\nParticipants will:\n\n* Receive MT-304 alone (every 14 days) or with nivolumab (every 28 days).\n* Attend regular clinic visits for assessments and monitoring.\n* Continue treatment until disease progression, unacceptable toxicity, or study discontinuation.",[59],"HER2-Expressing Solid Tumors",[61,62,63,64,65,66,67,68,69,70,71,72,73],"Anti-HER2 chimeric antigen receptor","Chimeric Antigen Receptor (CAR)","mRNA","Lipid nanoparticle (LNP)","Urothelial carcinoma","Endometrial carcinoma","Ovarian epithelial carcinoma","Breast carcinoma (all subtypes)","Gastric adenocarcinoma","Esophageal adenocarcinoma","Non-small cell lung cancer","Colorectal carcinoma","Biliary cancer (including Gallbladder carcinoma and extrahepatic cholangiocarcinoma)","2026-05-18",{"date":76,"type":38},"2026-05-20",{"date":78,"type":38},"2025-11-25",{"date":80,"type":21},"2028-03-30",{"name":82,"class":45},"Myeloid Therapeutics",7]