Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
Qualifiers
Histologically confirmed advanced clear cell RCC
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
Disqualifiers
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Patients who are receiving any other investigational agents.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to girentuximab.
Patients with uncontrolled intercurrent illness at the discretion of the investigator.
Trial design
Treatments tested in this trial
- Belzutifan
- 89Zr-DFO-girentuximab
- 89Zr-DFO-girentuximab PET
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
NYU Langone Health
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov