Actively Recruiting
Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC)
Led by NYU Langone Health · Updated on 2025-09-23
12
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced clear cell renal cell carcinoma
- Radiographic progression after prior immune checkpoint inhibitor therapy for renal cell carcinoma
- Measurable disease by RECIST v1.1
- Recovery to baseline or Grade 1 toxicities from prior treatments unless clinically nonsignificant and stable
- 18 years of age or older
- Karnofsky performance score of 60% or higher
- Adequate organ and marrow function including neutrophils 2 1,000/mcL, platelets 2 100,000/mcL, bilirubin within normal limits, AST/ALT 2 3 times upper limit of normal, creatinine or GFR within institutional limits
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months
- Patients with controlled chronic hepatitis B virus infection or treated hepatitis C virus infection
- Patients with treated brain metastases showing no progression or with active brain metastases not requiring immediate CNS therapy
- Patients with prior or concurrent malignancies not interfering with study assessments
- Cardiac function classified as New York Heart Association Class 2B or better
- Agreement to use adequate contraception during the study starting with 89Zr-DFO-girentuximab administration
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Unresolved adverse events from prior anti-cancer therapy greater than Grade 1 except alopecia
- Receiving other investigational agents
- History of allergic reactions to compounds similar to girentuximab
- Uncontrolled intercurrent illness as determined by investigator
- Pregnancy due to potential teratogenic or abortifacient effects of belzutifan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
C
Cancer Trials (NYU Langone Health Perlmutter Cancer Center)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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