A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma

Recruiting now · Phase 1

Conditions studied: Renal Cell Carcinoma

In brief

This is a Phase 1b, open-label, multicenter, safety, tolerability and efficacy study of HC-7366 in combination with belzutifan (WELIREG™). This is a multipart study that consists of a HC-7366 monotherapy cohort, a combination dose escalation, and a combination dose expansion. Approximately 80 patients will be enrolled in this study (up to 20 patients will be enrolled into the HC-7366 monotherapy cohort, up to 30 patients into the combination dose escalation, and up to 30 patients into the combination dose expansion). The primary purpose of this study is to determine the maximum tolerated dose of HC-7366 in combination with belzutifan in patients with locally advanced (inoperable) or metastatic RCC with predominantly clear cell histology, irrespective of VHL gene mutation status.

Key facts

Study ID

NCT06234605

Run by

HiberCell, Inc.

People needed

80

Starts

2024-04-29

Expected to finish

2027-11-01

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 is running

• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of Arizona Cancer Center — Tucson, Arizona, United States (enrolling)
• University of California San Diego Moores Cancer Center — La Jolla, California, United States (enrolling)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Rocky Mountain Cancer Centers, LLP — Lone Tree, Colorado, United States (enrolling)
• Yale - New Haven Hospital — New Haven, Connecticut, United States (enrolling)
• HealthPartners Cancer Research Center — Saint Paul, Minnesota, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Providence Cancer Institute — Portland, Oregon, United States (enrolling)
• SCRI Oncology Partners — Nashville, Tennessee, United States (enrolling)
• Texas Oncology — Dallas, Texas, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• University Medical Center & Texas Tech Health Science Center — Lubbock, Texas, United States (enrolling)
• Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
• Swedish Medical Center — Seattle, Washington, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• University of Wisconsin - Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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