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

NCT07179770 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-23

No results posted yet for this study

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.

Conditions

  • Metastatic Clear Cell Renal Cell Carcinoma

Interventions

DRUG

Belzutifan

120 mg orally daily for 28 days

DRUG

89Zr-DFO-girentuximab

10 mg single slow intravenous (IV) administration

DEVICE

89Zr-DFO-girentuximab PET

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

Sponsors & Collaborators

Principal Investigators

  • Minas Economides, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-09-01
Completion
2027-10-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07179770 on ClinicalTrials.gov