Actively Recruiting
A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
Led by HiberCell, Inc. · Updated on 2026-01-15
80
Participants Needed
20
Research Sites
183 weeks
Total Duration
On this page
Sponsors
H
HiberCell, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of locally advanced (inoperable) or metastatic renal cell carcinoma with a predominant clear cell component
- Age 18 years or older (male or female) at the time of consent
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 20 locations
1
University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Actively Recruiting
2
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States, 80124
Actively Recruiting
6
Yale - New Haven Hospital
New Haven, Connecticut, United States, 06520
Actively Recruiting
7
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
9
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
10
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
11
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
Providence Cancer Institute
Portland, Oregon, United States, 97213
Actively Recruiting
13
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
Texas Oncology
Dallas, Texas, United States, 75246
Actively Recruiting
15
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
16
University Medical Center & Texas Tech Health Science Center
Lubbock, Texas, United States, 79430
Actively Recruiting
17
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
Swedish Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
19
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
20
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
M
Michele Gargano
CONTACT
P
Paulette Mattson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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