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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 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
April 29, 2024
Primary Completion Date
November 1, 2026
Completion Date
November 1, 2027
Last Updated
January 15, 2026
80
ESTIMATED participants
HC-7366
DRUG
Belzutifan
DRUG
Lead Sponsor
HiberCell, Inc.
Collaborators
NCT07485114
NCT06391099
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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