Clinical trial Recruiting at 19 sites Phase 1 Interventional Ages 18 and up

Testing HC-7366 with Belzutifan for kidney cancer treatment

Official title: A Phase 1b, Open-Label, Safety, Tolerability, and Efficacy Study of HC- 7366 in Combination With Belzutifan (WELIREG™) in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

Run by HiberCell, Inc. · NCT06234605 · Data updated 2026-11-12

This study is testing a new treatment combining HC-7366 with belzutifan to see if it helps people with advanced kidney cancer feel better and live longer.

More Renal Cell Carcinoma trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment80 (estimated)
SponsorHiberCell, Inc.
Industry-sponsored
Locations21 sites (Tucson, Arizona and 20 other locations)
StatusRecruiting
StartedApril 29, 2024
Main results expectedNovember 2026
Study endsNovember 2027
Registry record updatedOctober 2, 2026
Trial IDNCT06234605 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with locally advanced or metastatic RCC characterized by a predominant clear cell component.

Probably not a fit

Patients with RCC that does not have a clear cell component or those who are not eligible for the specified treatment regimen may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1b clinical trial evaluates the safety, tolerability, and efficacy of HC-7366 in combination with belzutifan (WELIREG™) in patients with locally advanced or metastatic renal cell carcinoma (RCC) that has a predominant clear cell component. The study is designed as a multicenter, open-label trial that includes a monotherapy cohort and a combination dose escalation and expansion. Approximately 80 patients will be enrolled to determine the maximum tolerated dose of HC-7366 when used alongside belzutifan, regardless of VHL gene mutation status.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced kidney cancer.

How similar studies have gone: While this approach is novel in combining HC-7366 with belzutifan, similar studies have shown promise in treating advanced kidney cancer with targeted therapies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Has diagnosis of locally advanced (inoperable) or metastatic RCC with a predominant clear cell component
* Be age 18 years or older (male or female) at the time of consent

Where it's running

  • University of Arizona Cancer Center
    Tucson, Arizona, United States
    Recruiting
  • University of California San Diego Moores Cancer Center
    La Jolla, California, United States
    Recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
    Recruiting
  • University of Colorado Anschutz Medical Campus
    Aurora, Colorado, United States
    Recruiting
  • Rocky Mountain Cancer Centers, LLP
    Lone Tree, Colorado, United States
    Recruiting
  • Yale - New Haven Hospital
    New Haven, Connecticut, United States
    Recruiting
Show 15 more locations
  • HealthPartners Cancer Research Center
    Saint Paul, Minnesota, United States
    Recruiting
  • Washington University School of Medicine
    St Louis, Missouri, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio, United States
    Recruiting
  • Cleveland Clinic
    Cleveland, Ohio, United States
    Recruiting
  • Sarah Cannon Research Institute (SCRI)
    Nashville, Tennessee, United States
    Recruiting
  • Texas Oncology
    Dallas, Texas, United States
    Recruiting
  • University of Texas Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting
  • University Medical Center & Texas Tech Health Science Center
    Lubbock, Texas, United States
    Recruiting
  • Virginia Cancer Specialists
    Fairfax, Virginia, United States
    Recruiting
  • Swedish Medical Center
    Seattle, Washington, United States
    Recruiting
  • Fred Hutchinson Cancer Center
    Seattle, Washington, United States
    Recruiting
  • University of Wisconsin - Carbone Cancer Center
    Madison, Wisconsin, United States
    Recruiting
  • Karmanos Cancer Institute
    Detroit, Michigan, United States
    Withdrawn
  • Providence Cancer Institute
    Portland, Oregon, United States
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.