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
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.
Arms & interventions
- DrugBelzutifan
120 mg orally daily for 28 days
- Drug89Zr-DFO-girentuximab
10 mg single slow intravenous (IV) administration
- Device89Zr-DFO-girentuximab PET
89Zr-DFO-Girentuximab PET before and after 4 weeks of treatment with standard-of-care (SOC) belzutifan.
Outcome measures
Primary
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
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
Eligibility criteria
Study locations (1)
NYU Langone Health
New York, New York, 10016