A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
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
2 other identifiers
interventional
80
1 country
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Typical duration for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 31, 2024
CompletedStudy Start
First participant enrolled
April 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
January 15, 2026
January 1, 2026
2.5 years
January 9, 2024
January 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determination of MTD and RP2D (combination cohorts only)
To identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability and dose-limiting toxicities (DLTs) 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
30 months
Study Arms (2)
Monotherapy
EXPERIMENTALParticipants will receive HC-7366 monotherapy \[dose to be determined\] daily
Combination
EXPERIMENTALParticipants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily
Interventions
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.
Belzutifan is a potent and selective HIF-2α inhibitor
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- HiberCell, Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (20)
University of Arizona Cancer Center
Tucson, Arizona, 85719, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124, United States
Yale - New Haven Hospital
New Haven, Connecticut, 06520, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, 55101, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Providence Cancer Institute
Portland, Oregon, 97213, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Texas Oncology
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University Medical Center & Texas Tech Health Science Center
Lubbock, Texas, 79430, United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031, United States
Swedish Medical Center
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53705, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 31, 2024
Study Start
April 29, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2027
Last Updated
January 15, 2026
Record last verified: 2026-01