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

Neomorph, Inc

Status and phase

Enrolling

Phase 1

Conditions

VHL-Associated Renal Cell Carcinoma

VHL-Associated Clear Cell Renal Cell Carcinoma

Kidney Cancer Metastatic

Clear Cell Renal Cell Carcinoma Metastatic

RCC

Renal Cell Carcinoma

Kidney Cancers

Clear Cell Renal Cell Carcinoma

ccRCC

Treatments

Drug: NEO-811

Study type

Interventional

Funder types

Industry

Identifiers

NCT07300241

NEO-811-101

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.