RecruitingPhase 1NCT07179770

Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC)

A Phase 1b Study to Assess the Effects of Belzutifan on 89Zr-DFO-girentuximab Uptake as a Surrogate to Determine CAIX Tumor Expression in Patients With Clear Cell Renal Cell Carcinoma


Sponsor

NYU Langone Health

Enrollment

12 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to identify changes in Carbonic Anhydrase IX (CAIX) expression induced by hypoxia-inducible factor 2 alpha (HIF-2α) inhibition by initiating belzutifan single agent therapy and imaging CAIX expression with 89Zr-DFO-girentuximab PET before and 4 weeks after initiating treatment. This will be the first study to evaluate potential changes in CAIX expression altered by belzutifan. Information gained from this study will be leveraged to develop combinations of belzutifan with CAIX targeted agents including radioimmunotherapy in the future.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a drug called belzutifan affects the way a special PET scan tracer (89Zr-DFO-girentuximab) shows up in clear cell kidney cancer tumors. It helps researchers understand whether this tracer can be used to predict how well belzutifan is working. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with advanced clear cell kidney cancer (clear cell renal cell carcinoma) - Your cancer has gotten worse on or after prior immunotherapy treatment - You have measurable disease on imaging - You have received at least two previous treatments **You may NOT be eligible if...** - Your cancer is not the clear cell subtype - You have not had prior immunotherapy - You have severe organ problems or uncontrolled other illnesses - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelzutifan

120 mg orally daily for 28 days

DRUG89Zr-DFO-girentuximab

10 mg single slow intravenous (IV) administration

DEVICE89Zr-DFO-girentuximab PET

89Zr-DFO-Girentuximab PET before and after 4 weeks of treatment with standard-of-care (SOC) belzutifan.


Locations(1)

NYU Langone Health

New York, New York, United States

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NCT07179770


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