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

Sponsor: Neomorph, Inc • ClinicalTrials.gov ID: NCT07300241

Registry updated: 2026-10-05

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Description

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

Interventions

NEO-811 (Drug)
NEO-811

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.

Conditions

Clear Cell Renal Cell Carcinoma Renal Cell Carcinoma RCC Clear Cell Renal Cell Carcinoma Metastatic ccRCC VHL-Associated Clear Cell Renal Cell Carcinoma VHL-Associated Renal Cell Carcinoma Kidney Cancer Metastatic Kidney Cancers

Locations

NEO-811 Los Angeles Site — Duarte, California, United States
NEO-811 San Diego Site — San Diego, California, United States
NEO-811 Connecticut Site — New Haven, Connecticut, United States
NEO-811 Florida Site — Miami, Florida, United States
NEO-811 Chicago Site — Zion, Illinois, United States
NEO-811 Grand Rapids Site — Grand Rapids, Michigan, United States
NEO-811 Omaha Site — Omaha, Nebraska, United States
NEO-811 Long Island Site — Lake Success, New York, United States
NEO-811 NYC Site — New York, New York, United States
NEO-811 Cleveland Site — Cleveland, Ohio, United States
NEO-811 South Carolina Site — Myrtle Beach, South Carolina, United States
NEO-811 Dallas Site — Dallas, Texas, United States
NEO-811 Houston Site — Houston, Texas, United States
NEO-811 Virginia Site — Fairfax, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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