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

Inclusion Criteria

• •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:
• •* Hemoglobin ≥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.