Clear Cell Renal Cell Carcinoma study: NEO-811
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 oral medicine being studied for the treatment of locally advanced or metastatic 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
- This study is testing whether NEO-811 is safe and how it works in people with advanced kidney cancer.
- Who it's for
- You may be able to join if you have clear cell kidney cancer that has spread or cannot be removed by surgery.
- What's involved
- You will receive NEO-811 as a single treatment. The study will monitor your health and check for side effects.
- Time commitment
- The study lasts several weeks to months, with regular visits to the clinic for treatment and health checks.
- 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.
- 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 is enrolling
- Duarte, California, United States
- San Diego, California, United States
- New Haven, Connecticut, United States
- Miami, Florida, United States
- Zion, Illinois, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Lake Success, New York, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, 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, but 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?
This study is enrolling now at Duarte, California, United States; San Diego, California, United States; New Haven, Connecticut, United States; Miami, Florida, United States; Zion, Illinois, United States; Grand Rapids, Michigan, United States and 10 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.