Phase 1 Kidney Cancer Trial, Recruiting NCT07179770 Sponsor: NYU Langone Health Condition: Kidney Cancer
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Phase 1 Kidney Cancer Trial, Recruiting

NCT07179770
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been diagnosed with advanced clear cell kidney cancer (confirmed through a tissue sample test)
  • People whose kidney cancer has continued to grow or spread on imaging scans after being treated with a type of immunotherapy called a checkpoint inhibitor — either during or after treatment in the first-line (initial) setting, or within 6 months after finishing adjuvant (preventive post-surgery) immunotherapy
  • People who have received at least two previous treatment courses for their cancer (there is no upper limit on how many prior treatments)
  • People who have measurable tumours visible on imaging scans, based on standard measurement guidelines
  • People who have recovered from side effects of previous cancer treatments to near their original health levels, unless any remaining side effects are considered minor and stable by the treating doctor
  • People aged 18 and over
  • People with a Karnofsky performance score of 60% or higher, which is a medical measure of how well a person can carry out daily activities (confirm with trial site)
  • People whose blood counts, liver function, and kidney function meet specific minimum levels set by the trial — some flexibility may be allowed if results outside the range are not considered clinically significant by the lead investigator, and reference ranges may account for variations related to race, ethnicity, age, sex, or gender identity
  • People living with HIV who are on effective treatment and have had an undetectable amount of virus in their blood within the past 6 months
  • People with chronic hepatitis B who have an undetectable viral load while on appropriate suppressive therapy
  • People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable hepatitis C viral load
  • People who have had brain tumours (spread from the kidney cancer) that have already been treated, where follow-up brain scans show the cancer has not continued to grow
  • People with new or worsening brain tumours or cancer spread to the lining of the brain, if the treating doctor determines that urgent brain-specific treatment is not needed right away or is unlikely to be needed in the first treatment cycle
  • People who have or have had another cancer, as long as that cancer or its treatment is not expected to interfere with the safety or results of this trial
  • People with a known history of heart disease or prior treatment with heart-affecting medications, provided a heart function assessment places them at Class 2B or better using a standard heart classification system (confirm with trial site)
  • People who agree to use an adequate method of contraception throughout the study, beginning from the time of the first study imaging agent dose
  • People who are willing and able to understand and sign a written consent form

Who may not be able to join:

  • People who have not recovered from side effects of previous cancer treatment (side effects still rated above a mild level), except for hair loss
  • People currently taking part in another clinical trial involving an experimental treatment
  • People who have had a serious allergic reaction to a drug with a similar makeup to girentuximab (the imaging agent used in this trial)
  • People with another illness that is not well controlled, as determined by the investigator
  • People who are pregnant, as one of the trial drugs (belzutifan) carries a risk of harming an unborn baby

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Minas Economides, MD, NYU Langone Health

Phone: 212-263-4432

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
15 September 2025
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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; Standardized Uptake Value (SUV) peak uptake on 89Zr-DFO-girentuximab PET in ccRCC lesions between baseline and 4 weeks after initiation of belzutifan treatment; Occurrence of one or more grade 3 or higher toxicities by CTCAE v5 criteria

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov