Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

Who May Qualify: - Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC). - Subjects must have progressed on or refused standard therapies. - Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1. - Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks. - Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study. - Measurable disease as defined by RECIST v1.1. - Adequate hematologic, hepatic, and renal function defined as: - blood count (hemoglobin) at least 10 g/dL, - Absolute neutrophil count ≥1000 cells/µL, - Platelet count ≥100,000/µL, - AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases, - Total bilirubin ≤1.5 × ULN, - Estimated glomerular filtration rate (eGFR) ≥60 mL/min. - Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug. - Other inclusion criteria per protocol. Who Should NOT Join This Trial: - Non-clear cell predominant RCC histologic subtypes. - Leptomeningeal disease or symptomatic active cancer that has spread to the brain with exceptions for asymptomatic treated cancer that has spread to the brain per protocol. - Prior or concurrent malignancies with exceptions per protocol. - History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection. - Other exclusion criteria per protocol. Always talk to your doctor about whether this trial is right for you.