NEO-811 for advanced or metastatic clear cell kidney cancer
An Open-Label, First-in-Human, Phase 1/2 Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
This study will try the experimental oral drug NEO-811 in people with locally advanced or metastatic clear cell kidney cancer who have progressed on or refused standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Neomorph, Inc Industry-sponsored |
| Locations | 7 sites (Grand Rapids, Michigan and 6 other locations) |
| Trial ID | NCT07300241 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with locally advanced or metastatic non-resectable clear cell renal cell carcinoma who have progressed on or refused standard therapies, have ECOG 0–1, measurable disease, adequate organ function, and available tumor tissue are ideal candidates.
Not a fit: Patients with non–clear-cell kidney cancers, poor performance status, inadequate organ function, inability to swallow oral medication, or unwillingness/unable to provide tumor tissue are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, NEO-811 could shrink tumors or slow disease progression and provide a new therapy option for patients with advanced ccRCC who have limited choices.
How similar studies have performed: NEO-811 is being tested in humans for the first time; while targeted therapies and immunotherapies have improved outcomes in ccRCC, this specific agent has not yet been studied in people.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grand Rapids, Michigan and 6 other locations
- NEO-811 Grand Rapids Site — Grand Rapids, Michigan, United States (Recruiting)
- NEO-811 Long Island Site — Lake Success, New York, United States (Recruiting)
- NEO-811-101 NYC Site — New York, New York, United States (Recruiting)
- NEO-811 South Carolina Site — Myrtle Beach, South Carolina, United States (Recruiting)
- NEO-811 Dallas Site — Dallas, Texas, United States (Recruiting)
- NEO-811 Houston Site — Houston, Texas, United States (Recruiting)
- NEO-811 Virginia Site — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Sara Weymer
- Email: clinicaltrials@neomorph.com
- Phone: +1 858-428-9800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.