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Site","Houston","77054",{"type":39,"coordinates":136},[137,138],-95.36327,29.76328,{"lat":138,"lon":137},{"facility":141,"status":32,"city":142,"state":143,"zip":144,"country":36,"countryCode":37,"cosmosGeoPoint":145,"geoPoint":149,"contacts":18},"NEO-811 Virginia Site","Fairfax","Virginia","22031",{"type":39,"coordinates":146},[147,148],-77.30637,38.84622,{"lat":148,"lon":147},{"type":151,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100616025","phase-1-open-label-phase-12-study-of-neo-811-in-subjects-with-locally-advanced-or-metastatic-non-resectable-clear-cell-renal-cell-carcinoma-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":162,"type":163},30,"ESTIMATED","INTERVENTIONAL",[166],"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. 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