Testing HC-7366 with Belzutifan for kidney cancer treatment
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
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 |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | HiberCell, Inc. Industry-sponsored |
| Locations | 20 sites (Tucson, Arizona and 19 other locations) |
| Trial ID | NCT06234605 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic RCC characterized by a predominant clear cell component.
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.
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 performed: While this approach is novel in combining HC-7366 with belzutifan, similar studies have shown promise in treating advanced kidney cancer with targeted therapies.
Eligibility criteria
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 this trial is running
Tucson, Arizona and 19 other locations
- 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)
- 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)
- Providence Cancer Institute — Portland, Oregon, United States (Recruiting)
- SCRI Oncology Partners — 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)
Study contacts
- Study coordinator: Michele Gargano
- Email: mgargano@hibercell.com
- Phone: 651-675-0300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.