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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | HiberCell, Inc. Industry-sponsored |
| Locations | 21 sites (Tucson, Arizona and 20 other locations) |
| Status | Recruiting |
| Started | April 29, 2024 |
| Main results expected | November 2026 |
| Study ends | November 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT06234605 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
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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
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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
- Study coordinator: Michele Gargano
- Email: mgargano@hibercell.com
- Phone: 651-675-0300
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.