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

Introduction

• Org Study ID: NEO-811-101
• NCT ID: NCT07300241
• Lead Sponsor Name: Neomorph, Inc
• Status: RECRUITING

Conditions

• Clear Cell Renal Cell Carcinoma

Brief Summary

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 Criteria

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.