Effects of Belzutifan on 89Zr-DFO-girentuximab PET Uptake in Patients With Renal Cell Carcinoma (RCC)

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07179770
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    120 mg orally daily for 28 days
  • 89Zr-DFO-girentuximab — DRUG
    10 mg single slow intravenous (IV) administration
  • 89Zr-DFO-girentuximab PET — DEVICE
    89Zr-DFO-Girentuximab PET before and after 4 weeks of treatment with standard-of-care (SOC) belzutifan.

Study Details

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.

Key Dates

Start date
Sep 15, 2025
Status verified
Sep 2025
Primary completion
Sep 1, 2027
Completion
Oct 1, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Previously treated metastatic clear cell RCC
    Patients will undergo imaging with \[89Zr\]Zr-DFO-girentuximab PET before and 28 days after treatment with belzutifan.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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By research site
NYU Langone Health· New York, NY

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