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

Recruiting now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT07300241

Run by

Neomorph, Inc

People needed

30

Starts

2025-12-19

Expected to finish

2027-09-01

Last updated by the study team

2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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