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

StatusWithdrawn
PhasePhase 1
Started

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Record History

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  1. Trial status changed: Recruiting → Withdrawn Sponsor's reason: PI Departure
    • Enrollment target: estimated 12 to confirmed 0
    • Eligibility criteria expanded, about 32 words
    • Site details revised
  2. Primary completion pushed from Sep 1, 2027 to Sep 1, 2028
    • Study completion pushed from Oct 1, 2027 to Oct 1, 2028
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2025 to Sep 15, 2025
    • Site details revised
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT07179770
Lead Sponsor NYU Langone Health
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Metastatic Clear Cell Renal Cell Carcinoma
Related terms Clear-cell metastatic renal cell carcinoma
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov