Actively Recruiting
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
Led by NYU Langone Health · Updated on 2025-09-23
12
Participants Needed
1
Research Sites
4 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
Researchers are studying the effects of belzutifan, a drug that inhibits hypoxia-inducible factor 2 alpha (HIF-2α), on Carbonic Anhydrase IX (CAIX) expression in patients with metastatic clear cell renal cell carcinoma (ccRCC). This Phase 1b study aims to observe changes in CAIX expression using a special imaging technique called 89Zr-DFO-girentuximab PET before and after starting belzutifan treatment. The results will help guide future combinations of belzutifan with CAIX-targeted therapies, including radioimmunotherapy. Participants will receive belzutifan orally once daily at 120 mg for 28 days. They will undergo two imaging sessions with 89Zr-DFO-girentuximab PET: one before starting belzutifan and another 28 days after beginning treatment. The PET imaging involves a single slow intravenous injection of 10 mg of 89Zr-DFO-girentuximab to visualize CAIX expression in tumors. During the study, researchers will measure changes in the standardized uptake value (SUV) of 89Zr-DFO-girentuximab PET in ccRCC lesions at baseline and after four weeks of belzutifan treatment. They will monitor for any severe toxicities (grade 3 or higher) using established criteria. Participants will be followed closely for safety and treatment response over the study period.
CONDITIONS
Brief 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 disease progression after prior immune checkpoint inhibitor therapy for renal cell carcinoma
- Measurable disease according to RECIST v1.1 criteria
- Recovery to baseline or Grade 1 from prior treatment toxicities, unless stable or clinically nonsignificant
- Age greater than 18 years
- Karnofsky performance score of 60% or higher
- Adequate organ and marrow function as defined by specific laboratory criteria
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
- Patients with controlled chronic hepatitis B or treated hepatitis C infection
- Patients with treated brain metastases without progression or stable new brain metastases if immediate treatment is not required
- Patients with prior or concurrent malignancies that do not interfere 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 willingness to sign informed consent
You will not qualify if you...
- Unrecovered toxicities greater than Grade 1 from prior anti-cancer therapy, except alopecia
- Receiving any other investigational agents
- History of allergic reactions to compounds similar to girentuximab
- Uncontrolled intercurrent illness as judged by the investigator
- Pregnant women due to potential risks of belzutifan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants take belzutifan orally daily for 28 days and receive a single intravenous administration of 89Zr-DFO-girentuximab. Imaging with 89Zr-DFO-girentuximab PET is done before treatment and after 28 days of belzutifan.
1 baseline visit and 1 follow-up visit for PET imaging
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)
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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