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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
120 mg orally daily for 28 days
10 mg single slow intravenous (IV) administration
89Zr-DFO-Girentuximab PET before and after 4 weeks of treatment with standard-of-care (SOC) belzutifan.
NYU Langone Health
New York, New York, United States
RECRUITINGChange 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
Time frame: Baseline, 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 treatment
Time frame: Baseline, Week 4
Occurrence of one or more grade 3 or higher toxicities by CTCAE v5 criteria
Time frame: Week 4
Cancer Trials (NYU Langone Health Perlmutter Cancer Center)
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