[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616025":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":29,"responsibleParty":129,"collaborators":18,"id":131,"slug":18,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":18,"eligibilityCriteria":136,"healthyVolunteers":132,"sex":137,"minAge":138,"maxAge":18,"enrollmentInfo":139,"targetDuration":18,"studyType":142,"phases":143,"briefSummary":145,"conditions":146,"keywords":156,"overallStatus":32,"whyStopped":18,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Neomorph, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single agent NEO-811 dose escalation","EXPERIMENTAL","NEO-811",[13],"Drug: NEO-811",[15],{"type":16,"name":11,"description":11,"armGroupLabels":17,"otherNames":18},"DRUG",[9],null,[20],{"name":21,"affiliation":5,"role":22},"Klaus Wagner, MD, PhD","STUDY_DIRECTOR",[24],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Sara Weymer","CONTACT","+1 858-428-9800","clinicaltrials@neomorph.com",[30,43,52,62,72,82,90,100,110,119],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":18},"NEO-811 Los Angeles Site","RECRUITING","Duarte","California","91010","United States",{"type":38,"coordinates":39},"Point",[40,41],-117.97729,34.13945,{"lat":41,"lon":40},{"facility":44,"status":32,"city":45,"state":34,"zip":46,"country":36,"cosmosGeoPoint":47,"geoPoint":51,"contacts":18},"NEO-811 San Diego Site","San Diego","92037",{"type":38,"coordinates":48},[49,50],-117.16472,32.71571,{"lat":50,"lon":49},{"facility":53,"status":32,"city":54,"state":55,"zip":56,"country":36,"cosmosGeoPoint":57,"geoPoint":61,"contacts":18},"NEO-811 Chicago Site","Zion","Illinois","60099",{"type":38,"coordinates":58},[59,60],-87.83285,42.44613,{"lat":60,"lon":59},{"facility":63,"status":32,"city":64,"state":65,"zip":66,"country":36,"cosmosGeoPoint":67,"geoPoint":71,"contacts":18},"NEO-811 Grand Rapids Site","Grand Rapids","Michigan","49503",{"type":38,"coordinates":68},[69,70],-85.66809,42.96336,{"lat":70,"lon":69},{"facility":73,"status":32,"city":74,"state":75,"zip":76,"country":36,"cosmosGeoPoint":77,"geoPoint":81,"contacts":18},"NEO-811 Long Island Site","Lake Success","New York","11042",{"type":38,"coordinates":78},[79,80],-73.71763,40.77066,{"lat":80,"lon":79},{"facility":83,"status":32,"city":75,"state":75,"zip":84,"country":36,"cosmosGeoPoint":85,"geoPoint":89,"contacts":18},"NEO-811 NYC Site","10065",{"type":38,"coordinates":86},[87,88],-74.00597,40.71427,{"lat":88,"lon":87},{"facility":91,"status":32,"city":92,"state":93,"zip":94,"country":36,"cosmosGeoPoint":95,"geoPoint":99,"contacts":18},"NEO-811 South Carolina Site","Myrtle Beach","South Carolina","29572",{"type":38,"coordinates":96},[97,98],-78.88669,33.68906,{"lat":98,"lon":97},{"facility":101,"status":32,"city":102,"state":103,"zip":104,"country":36,"cosmosGeoPoint":105,"geoPoint":109,"contacts":18},"NEO-811 Dallas Site","Dallas","Texas","75039",{"type":38,"coordinates":106},[107,108],-96.80667,32.78306,{"lat":108,"lon":107},{"facility":111,"status":32,"city":112,"state":103,"zip":113,"country":36,"cosmosGeoPoint":114,"geoPoint":118,"contacts":18},"NEO-811 Houston Site","Houston","77054",{"type":38,"coordinates":115},[116,117],-95.36327,29.76328,{"lat":117,"lon":116},{"facility":120,"status":32,"city":121,"state":122,"zip":123,"country":36,"cosmosGeoPoint":124,"geoPoint":128,"contacts":18},"NEO-811 Virginia Site","Fairfax","Virginia","22031",{"type":38,"coordinates":125},[126,127],-77.30637,38.84622,{"lat":127,"lon":126},{"type":130,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100616025",false,"NCT07300241","Open-Label Phase 1\u002F2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","An Open-Label, First-in-Human, Phase 1\u002F2 Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).\n* Subjects must have progressed on or refused standard therapies.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.\n* Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.\n* Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study.\n* Measurable disease as defined by RECIST v1.1.\n* Adequate hematologic, hepatic, and renal function defined as:\n\n  * Hemoglobin ≥10 g\u002FdL,\n  * Absolute neutrophil count ≥1000 cells\u002FµL,\n  * Platelet count ≥100,000\u002FµL,\n  * AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases,\n  * Total bilirubin ≤1.5 × ULN,\n  * Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin.\n* Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug.\n* Other inclusion criteria per protocol.\n\nExclusion Criteria:\n\n* Non-clear cell predominant RCC histologic subtypes.\n* Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.\n* Prior or concurrent malignancies with exceptions per protocol.\n* History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.\n* Other exclusion criteria per protocol.","ALL","18 Years",{"count":140,"type":141},30,"ESTIMATED","INTERVENTIONAL",[144],"PHASE1","The NEO-811-101 study is an open-label, first-in-human, Phase 1\u002F2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.",[147,148,149,150,151,152,153,154,155],"Clear Cell Renal Cell Carcinoma","Renal Cell Carcinoma","RCC","Clear Cell Renal Cell Carcinoma Metastatic","ccRCC","VHL-Associated Clear Cell Renal Cell Carcinoma","VHL-Associated Renal Cell Carcinoma","Kidney Cancer Metastatic","Kidney Cancers",[151,148,147,157,158],"VHL","Kidney Cancer","2026-05-29",{"date":161,"type":162},"2026-06-02","ACTUAL",{"date":164,"type":162},"2025-12-19",{"date":166,"type":141},"2027-09",{"name":5,"class":6},10]