NEO-811 for advanced or metastatic clear cell kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, first-in-human Phase 1/2 study uses a dose-escalation and expansion design to test NEO-811 initially as a monotherapy in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. Eligible participants must have measurable disease by RECIST v1.1, ECOG performance status 0 or 1, adequate blood and organ function, and available tumor tissue (new or archival FFPE). The trial will enroll at multiple U.S. sites and will determine a safe dose range and collect early evidence of anti-tumor activity and safety signals. Safety, tolerability, and preliminary efficacy endpoints will guide dose selection for expansion cohorts.

Why it matters

Who can join: the full rules

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.

Where it's running

• NEO-811 Los Angeles Site
  Duarte, California, United States Recruiting
• NEO-811 San Diego Site
  San Diego, California, United States Recruiting
• NEO-811 Connecticut Site
  New Haven, Connecticut, United States Recruiting
• NEO-811 Florida Site
  Miami, Florida, United States Recruiting
• NEO-811 Chicago Site
  Zion, Illinois, United States Recruiting
• NEO-811 Grand Rapids Site
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Sara Weymer
• Email: clinicaltrials@neomorph.com
• Phone: +1 858-428-9800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.