NCT07179770

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-09-15
• Primary completion: 2027-09-01
• Completion: 2027-10-01
• First posted: 2025-09-18
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study