NCT07300241 · Neomorph, Inc
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
What this study is about
The NEO-811-101 study is an where both patients and doctors know the treatment given, first-in-human, Phase 1/2 gradually increasing doses 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 treatment given alone.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Duarte, California
- San Diego, California
- Zion, Illinois
- Grand Rapids, Michigan
- Lake Success, New York
- New York, New York
- Myrtle Beach, South Carolina
- Dallas, Texas
- Houston, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations