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

ConditionMetastatic Clear Cell Renal Cell Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Previously treated metastatic clear cell RCCExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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
2

Standardized Uptake Value (SUV) peak uptake on 89Zr-DFO-girentuximab PET in ccRCC lesions between baseline and 4 weeks after initiation of belzutifan treatment

Time frame
Baseline, Week 4
3

Occurrence of one or more grade 3 or higher toxicities by CTCAE v5 criteria

Time frame
Week 4

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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