NYU Langone Health
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.
Inclusion Criteria: 1. Histologically confirmed advanced clear cell RCC 2. Radiographic disease progression to prior immune checkpoint inhibitor (ICI) therapy for RCC * 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…
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.
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