Overview

The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study of NEO-811 for subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.

Eligibility

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.
• Other inclusion criteria per protocol.

Exclusion Criteria:

• Non-clear cell predominant RCC histologic subtypes.
• Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic 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.