[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606945":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":115,"collaborators":19,"id":117,"slug":19,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":19,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":19,"enrollmentInfo":125,"targetDuration":19,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":143,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Normunity AccelCo, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NRM-823","EXPERIMENTAL","Administered per protocol requirements",[13],"Drug: NRM-823",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","NRM-823 is a bispecific T-Cell Engager",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Viviana Bozon, MD","STUDY_DIRECTOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Judy Schnyder, MBA","CONTACT","215-593-7119","judy.schnyder@normunity.com",[31,44,53,62,71,80,89,98,106],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":19},"Normunity Investigational Site","RECRUITING","Denver","Colorado","80220","United States",{"type":39,"coordinates":40},"Point",[41,42],-104.9847,39.73915,{"lat":42,"lon":41},{"facility":32,"status":33,"city":45,"state":46,"zip":47,"country":37,"cosmosGeoPoint":48,"geoPoint":52,"contacts":19},"New Haven","Connecticut","06519",{"type":39,"coordinates":49},[50,51],-72.92816,41.30815,{"lat":51,"lon":50},{"facility":32,"status":33,"city":54,"state":55,"zip":56,"country":37,"cosmosGeoPoint":57,"geoPoint":61,"contacts":19},"Minneapolis","Minnesota","55425",{"type":39,"coordinates":58},[59,60],-93.26384,44.97997,{"lat":60,"lon":59},{"facility":32,"status":33,"city":63,"state":64,"zip":65,"country":37,"cosmosGeoPoint":66,"geoPoint":70,"contacts":19},"Maumee","Ohio","43537",{"type":39,"coordinates":67},[68,69],-83.65382,41.56283,{"lat":69,"lon":68},{"facility":32,"status":33,"city":72,"state":73,"zip":74,"country":37,"cosmosGeoPoint":75,"geoPoint":79,"contacts":19},"Philadelphia","Pennsylvania","19107",{"type":39,"coordinates":76},[77,78],-75.16362,39.95238,{"lat":78,"lon":77},{"facility":32,"status":33,"city":81,"state":82,"zip":83,"country":37,"cosmosGeoPoint":84,"geoPoint":88,"contacts":19},"Nashville","Tennessee","37203",{"type":39,"coordinates":85},[86,87],-86.78444,36.16589,{"lat":87,"lon":86},{"facility":32,"status":33,"city":90,"state":91,"zip":92,"country":37,"cosmosGeoPoint":93,"geoPoint":97,"contacts":19},"Dallas","Texas","75230",{"type":39,"coordinates":94},[95,96],-96.80667,32.78306,{"lat":96,"lon":95},{"facility":32,"status":33,"city":99,"state":91,"zip":100,"country":37,"cosmosGeoPoint":101,"geoPoint":105,"contacts":19},"San Antonio","78229",{"type":39,"coordinates":102},[103,104],-98.49363,29.42412,{"lat":104,"lon":103},{"facility":32,"status":33,"city":107,"state":108,"zip":109,"country":37,"cosmosGeoPoint":110,"geoPoint":114,"contacts":19},"Fairfax","Virginia","22031",{"type":39,"coordinates":111},[112,113],-77.30637,38.84622,{"lat":113,"lon":112},{"type":116,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100606945",false,"NCT07182149","A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","A Phase 1a\u002F1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors","Inclusion Criteria:\n\n* Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric\u002FGEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Adequate liver, renal, pulmonary, and cardiac function.\n* Adequate hematologic function.\n\nExclusion Criteria:\n\n* Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823\n* History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy.\n* Has received an investigational therapy \\\u003C4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823.\n* With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.","ALL","18 Years",{"count":126,"type":127},150,"ESTIMATED","INTERVENTIONAL",[130],"PHASE1","This study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.",[133,134,135,136,137,138,139,140,141,142],"HNSCC","ESCC","Esophageal Adenocarcinoma","Gastric Adenocarcinoma","GEJ Adenocarcinoma","Ovarian Cancer","NSCLC","Cervical Cancer","Endometrial Cancer","Triple Negative Breast Cancer (TNBC)",[9],"2026-02-10",{"date":146,"type":147},"2026-02-12","ACTUAL",{"date":149,"type":147},"2025-10-30",{"date":151,"type":127},"2028-10-31",{"name":5,"class":6},9]