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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: HiberCell, Inc. · Participants: 80 · Started: Apr 29, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06234605

Locations in the U.S.

ArizonaUniversity of Arizona Cancer Center, Tucson
CaliforniaUniversity of California San Diego Moores Cancer Center, La Jolla
Cedars-Sinai Medical Center, Los Angeles
ColoradoUniversity of Colorado Anschutz Medical Campus, Aurora
Rocky Mountain Cancer Centers, LLP, Lone Tree
ConnecticutYale - New Haven Hospital, New Haven
MinnesotaHealthPartners Cancer Research Center, Saint Paul
MissouriWashington University School of Medicine, St Louis
New YorkMemorial Sloan Kettering Cancer Center, New York
OhioCleveland Clinic, Cleveland
University Hospitals Cleveland Medical Center, Cleveland
OregonProvidence Cancer Institute, Portland
TennesseeSCRI Oncology Partners, Nashville
TexasTexas Oncology, Dallas
University of Texas Southwestern Medical Center, Dallas
University Medical Center & Texas Tech Health Science Center, Lubbock
VirginiaVirginia Cancer Specialists, Fairfax
WashingtonFred Hutchinson Cancer Center, Seattle
Swedish Medical Center, Seattle
WisconsinUniversity of Wisconsin - Carbone Cancer Center, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.