New study uses PET scans to see how kidney cancer drug changes key protein
NCT ID NCT07179770
First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This early-phase study is looking at how the drug belzutifan affects a protein called CAIX in people with advanced clear cell kidney cancer. Researchers will use a special PET scan before and after four weeks of belzutifan treatment to measure changes in CAIX levels. The goal is to gather information that could help design better combination treatments in the future. The study involves 12 participants and is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belzutifan (Welireg) and 89Zr-DFO-girentuximab (TLX250-CDx)
- What this could lead to
- If successful, this study could show how belzutifan affects CAIX levels, paving the way for more effective combination therapies for advanced kidney cancer.
- What could go wrong
- This is a very small, early-phase study with only 12 participants, so results may not apply broadly. The imaging technique is experimental, and the main goal is to gather information, not to test a new treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed advanced clear cell RCC 2. Radiographic disease progression to prior immune checkpoint inhibitor (ICI) therapy for RCC * ICI for adjuvant therapy: Patients who experienced radiographic tumor progression during or within 6 months after last dose of adjuvant ICI * ICI for locally advanced or metastatic disease: radiographic disease progression during or following ICI treatment in the 1st line setting * Minimum two previous treatment regimens but no maximum limit 3. Measurable disease per RECIST v1.1 4. Recovery to baseline or Grade1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable in the opinion of the investigator. 5. Age\>18 years of age 6. Karnofsky performance score ≥60% 7. Patients must have adequate organ and marrow function as defined below: * absolute neutrophil count ≥1,000/mcL * platelets ≥100,000/mcL * total bilirubin ≤ institutional upper limit of normal (ULN) * Aspartate Aminotransferase (AST) (SGOT)/Alanine Aminotransferase (ALT) (SGPT ≤3 × institutional ULN * creatinine ≤ institutional ULN OR * glomerular filtration rate (GFR) ≥60 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 1. Patients with abnormal test results outside the allowable range, but are not clinically significant, may still enroll with PI's review and approval. 2. Laboratory reference values should account for potential normal variations due to race, ethnicity, age, sex, and gender identity (e.g., due to surgical and/or hormonal changes). 8. Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 9. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 10. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 11. Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. 12. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy. 13. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 14. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. 15. Patients who agree to use an adequate method of contraception throughout the study period, starting with the administration of 89Zr-DFO-girentuximab, 16. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia. 2. Patients who are receiving any other investigational agents. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to girentuximab. 4. Patients with uncontrolled intercurrent illness at the discretion of the investigator. 5. Pregnant women are excluded from this study because belzutifan is an agent with the potential for teratogenic or abortifacient effects.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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- Can a Patient's own immune cells beat advanced kidney cancer?
- Can a pill rewrite the genetic story of resistant kidney cancer?