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A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
Sponsor: HiberCell, Inc.
Summary
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-04-29
Completion Date
2027-11
Last Updated
2026-01-15
Healthy Volunteers
No
Conditions
Interventions
HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.
Belzutifan
Belzutifan is a potent and selective HIF-2α inhibitor
Locations (20)
University of Arizona Cancer Center
Tucson, Arizona, United States
University of California San Diego Moores Cancer Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
Yale - New Haven Hospital
New Haven, Connecticut, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence Cancer Institute
Portland, Oregon, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
Texas Oncology
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University Medical Center & Texas Tech Health Science Center
Lubbock, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, United States