Belzutifan for Kidney Cancer

Overseen By Cancer Trials (NYU Langone Health Perlmutter Cancer Center)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NYU Langone Health

Must not be taking: Investigational agents

Disqualifiers: Uncontrolled illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called belzutifan for individuals with advanced kidney cancer, specifically clear cell renal cell carcinoma (RCC), that has spread and worsened after previous treatments. Researchers aim to observe how belzutifan affects a specific protein linked to cancer cells and use imaging to track these changes. The goal is to gather information that might help combine belzutifan with other treatments in the future. This trial may suit those who have already tried at least two cancer treatments and have seen their cancer progress after immunotherapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that belzutifan, a treatment for certain kidney cancers, has promising safety results. It is already approved for treating tumors linked to Von Hippel-Lindau (VHL) disease and some kidney cancers, indicating it is generally well-tolerated. Studies found that patients managed side effects effectively. Common side effects included fatigue, nausea, and low red blood cell count, but these were usually mild to moderate. Serious side effects occurred less frequently. This information offers a clear understanding of belzutifan's safety for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Belzutifan is unique because it targets the HIF-2α protein, which is involved in the growth of kidney cancer cells, offering a novel approach compared to the standard treatments like tyrosine kinase inhibitors and immune checkpoint inhibitors. Researchers are excited about belzutifan because it specifically disrupts the cancer's ability to adapt to low oxygen environments, which is crucial for tumor growth. This targeted action could potentially lead to more effective and less toxic treatment options for patients with metastatic clear cell renal cell carcinoma.

What evidence suggests that belzutifan might be an effective treatment for kidney cancer?

Research has shown that belzutifan may effectively treat clear cell renal cell carcinoma (ccRCC), a type of kidney cancer. In earlier studies, patients taking belzutifan lived for an average of 8.5 months without cancer progression. Additionally, 36.4% of patients experienced a significant reduction in tumor size. Another study found that belzutifan improved the time patients lived without cancer progression compared to everolimus, with a risk reduction of 25%. These results suggest that belzutifan could be a promising treatment option for kidney cancer. Participants in this trial will receive belzutifan and undergo imaging with [89Zr]Zr-DFO-girentuximab PET before and 28 days after treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Minas Economides, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients with Renal Cell Carcinoma (RCC). Participants should have measurable levels of a protein called CAIX, which the study drugs target. Specific eligibility criteria are not provided, but typically include factors like overall health status and prior treatments.

Inclusion Criteria

Measurable disease per RECIST v1.1

Patients who agree to use an adequate method of contraception throughout the study period, starting with the administration of 89Zr-DFO-girentuximab

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive belzutifan therapy and undergo imaging with 89Zr-DFO-girentuximab PET before and 4 weeks after initiating treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Belzutifan

Trial Overview The study tests Belzutifan's effect on RCC by measuring changes in CAIX expression using a special PET scan with 89Zr-DFO-girentuximab before and after treatment. This could help develop future therapies that target CAIX.

How Is the Trial Designed?

Group I: Previously treated metastatic clear cell RCC Experimental Treatment 3 Interventions

Patients will undergo imaging with \[89Zr\]Zr-DFO-girentuximab PET before and 28 days after treatment with belzutifan.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12509838/

59: Real-World efficacy and safety of belzutifan in sporadic ... At the start of therapy, baseline liver metastases and peritoneal disease were present in 33% and 19% of patients, respectively; 30% had bone ...

2. physiciansweekly.com physiciansweekly.com/post/real-world-outcomes-of-belzutifan-in-heavily-pretreated-sporadic-metastatic-ccrcc

Belzutifan Real-World Data: 8.5-Month PFS in ccRCC Real-world analysis shows belzutifan achieved 8.5-month PFS and 36.4% ORR in heavily pretreated metastatic ccRCC patients after ...

3. accpjournals.onlinelibrary.wiley.com accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.70023

Belzutifan's role in the treatment landscape of clear cell renal ... There was no significant difference in median overall survival, with 21.4 months for belzutifan and 18.1 months for everolimus (hazard ratio [HR] ...

4. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-advanced-renal-cell-carcinoma

FDA approves belzutifan for advanced renal cell carcinoma A statistically significant improvement in PFS was demonstrated for belzutifan compared with everolimus, with a hazard ratio of 0.75 [(95% CI: ...

5. urotoday.com urotoday.com/conference-highlights/asco-gu-2025/asco-gu-2025-kidney-cancer/158330-asco-gu-2025-updated-results-from-the-phase-2-litespark-003-study-of-belzutifan-plus-cabozantinib-in-patients-with-advanced-clear-cell-renal-cell-carcinoma.html

Updated Results From the Phase 2 LITESPARK-003 Study ... Dr. Toni Choueiri presented updated results from the phase II LITESPARK-003 study of belzutifan plus cabozantinib in patients with advanced clear cell renal ...

6. bmcpharmacoltoxicol.biomedcentral.com bmcpharmacoltoxicol.biomedcentral.com/articles/10.1186/s40360-024-00828-5

The efficacy and safety of belzutifan inhibitor in patients with ... The efficacy and safety of belzutifan inhibitor in patients with advanced or metastatic clear cell renal cell carcinoma: a meta-analysis. Ge ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07023432

Belzutifan's Role in Active Surveillance Versus Treatment ... To learn if belzutifan can help to control the disease in patients with metastatic RCC who are considered candidates for active surveillance.

8. welireghcp.com welireghcp.com/advanced-renal-cell-carcinoma/

Advanced Clear Cell Renal Cell Carcinoma (ccRCC) ... Health care professionals may find information, including efficacy and safety data about a treatment option for certain adults with advanced ccRCC. Explore here