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New treatment option for Clear Cell Renal Cell Carcinoma
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
ClinicalTrials.gov ID: NCT07300241
What this study is testing
What is NEO-811?
NEO-811 is an investigational medicine, being studied as a potential treatment for clear cell renal cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).
- people 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.
You likely can't join 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.
See the full eligibility criteria
- people with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).
- people 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 people 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 per protocol.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- San Diego, California, United States
- New Haven, Connecticut, United States
- Zion, Illinois, United States
- Grand Rapids, Michigan, United States
- Lake Success, New York, United States
- New York, New York, United States
- Myrtle Beach, South Carolina, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; San Diego, California, United States; New Haven, Connecticut, United States; Zion, Illinois, United States; Grand Rapids, Michigan, United States; Lake Success, New York, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.