Belzutifan and 89Zr-DFO-girentuximab PET in Kidney Cancer

This study is looking at how a drug called belzutifan affects certain proteins in people with advanced clear cell kidney cancer (renal cell carcinoma or RCC). You may be able to join if you have advanced clear cell RCC that has gotten worse after prior immunotherapy. Researchers will give you belzutifan daily for 28 days and a single dose of 89Zr-DFO-girentuximab, which helps them see specific proteins using a special scan (PET scan). The main goal is to see if belzutifan changes the amount of these proteins in your tumors and to check for any serious side effects after 4 weeks. This is the first study to explore these changes, hoping to find new ways to combine treatments in the future. The study aims to enroll 12 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is designed to evaluate changes in protein levels and side effects after treatment.
What's involved
You would take belzutifan daily for 28 days and receive one slow intravenous (IV) dose of 89Zr-DFO-girentuximab. You would have PET scans before and after 4 weeks of treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured at baseline and after 4 weeks of treatment with belzutifan.

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NCT07179770

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
NYU Langone Health
~12 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Belzutifan89Zr-DFO-girentuximab89Zr-DFO-girentuximab PET

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Standardized Uptake Value (SUV) max uptake on 89Zr-DFO-girentuximab PET in ccRCC lesions between baseline and 4 weeks after initiation of belzutifan treatment
Measured over Baseline, Week 4
+2 more outcomes measured
Metastatic Clear Cell Renal Cell Carcinoma
1 sites across 1 states
New York1
  • Minas Economides, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Cancer Trials (NYU Langone Health Perlmutter Cancer Center)
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
  • Change in Standardized Uptake Value (SUV) max uptake on 89Zr-DFO-girentuximab PET in ccRCC lesions between baseline and 4 weeks after initiation of belzutifan treatmentBaseline, Week 4
  • Standardized Uptake Value (SUV) peak uptake on 89Zr-DFO-girentuximab PET in ccRCC lesions between baseline and 4 weeks after initiation of belzutifan treatmentBaseline, Week 4
  • Occurrence of one or more grade 3 or higher toxicities by CTCAE v5 criteriaWeek 4