Actively Recruiting
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Led by Neomorph, Inc · Updated on 2026-03-11
30
Participants Needed
7
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 of at least 12 weeks as judged by the Investigator.
- Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is required.
- Measurable disease according to RECIST v1.1.
- Adequate hematologic function: Hemoglobin 9 g/dL, Absolute neutrophil count 1000 cells/b5L, Platelet count 100,000/b5L.
- Adequate hepatic function: AST and ALT 9 2.5 �d7 ULN, or 5 �d7 ULN for subjects with liver metastases, Total bilirubin 9 1.5 �d7 ULN.
- Adequate renal function: Estimated glomerular filtration rate (eGFR) 9 60 mL/min.
- Ability to swallow oral medications without conditions impairing drug absorption.
- Other inclusion criteria per protocol.
You will not qualify if you...
- 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.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
NEO-811 Grand Rapids Site
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
2
NEO-811 Long Island Site
Lake Success, New York, United States, 11042
Actively Recruiting
3
NEO-811-101 NYC Site
New York, New York, United States, 10065
Actively Recruiting
4
NEO-811 South Carolina Site
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
5
NEO-811 Dallas Site
Dallas, Texas, United States, 75039
Actively Recruiting
6
NEO-811 Houston Site
Houston, Texas, United States, 77054
Actively Recruiting
7
NEO-811 Virginia Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
S
Sara Weymer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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