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 cellcarcinoma (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 12weeks.

• Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, ismandatory 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 livermetastases,

• 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 impairthe oral bioavailability of the study drug.

• Other inclusion criteria per protocol.

Exclusion Criteria:

• Non-clear cell predominant RCC histologic subtypes.

• Leptomeningeal disease or symptomatic active CNS metastases with exceptions forasymptomatic treated CNS metastases 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.