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New study uses PET scans to see how kidney cancer drug changes key protein

NCT ID NCT07179770

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

clear cell renal carcinoma Clear-cell metastatic renal cell carcinoma nonpapillary renal cell carcinoma

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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