Recruiting
Phase 1

HC-7366 & Belzutifan

Sponsor:

HiberCell, Inc.

Code:

NCT06234605

Conditions

Renal Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HC-7366

Belzutifan

Study Details

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.

Conditions

Renal Cell Carcinoma

Study ID

NCT06234605

Start date

Apr 29, 2024

Status verified date

Jan, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Monotherapy

Participants will receive HC-7366 monotherapy \[dose to be determined\] daily

experimental: Combination

Participants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily

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

Primary outcome measure

  • Determination of MTD and RP2D (combination cohorts only) [ Time Frame: 30 months ]

Central Contacts and Locations

Central contacts

Michele Gargano

651-675-0300mgargano@hibercell.com

Paulette Mattson

651-675-0300pmattson@hibercell.com

Locations

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Thomas Schlaback

520-694-9090thomas2020@arizona.edu

Cindie Neal

520-626-6954cyndieneal@arizona.edu

University of California San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Karen Cuervo

kcuervo@health.ucsd.edu

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Linda Ford

linda.ford@cshs.org

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Elaine Lam, MD

elaine.lam@cuanschutz.edu

Rocky Mountain Cancer Centers, LLP

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Bobbie Donnachaidh

bobbie.donnachaidh@usoncology.com

Jennifer Hege

jennifer.hege@usoncology.com

Yale - New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

David Schoenfeld, MD

david.schoenfeld@yale.edu

HealthPartners Cancer Research Center

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Octav Pacurar

Octav.Pacurar@ParkNicollet.com

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Rachel Jacobi

jacobir@mskcc.org

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Kathryn Helminiak

kathryn.helminiak@UHhospitals.org

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

David Lynn

lynnd4@ccf.org

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

Contacts

Katrina Herz

Katrina.Herz@providence.org

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Emma Brennan

Emma.Brennan@scri.com

Lauren King

Lauren.King@scri.com

Texas Oncology

Recruiting

Dallas, Texas, United States, 75246

Contacts

Lisa Jones

lisa.jones1@usoncology.com

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Hans Hammers, MD

Hans.Hammers@utsouthwestern.edu

University Medical Center & Texas Tech Health Science Center

Recruiting

Lubbock, Texas, United States, 79430

Contacts

Thomas Hutson, MD

thomas.hutson@ttuhsc.edu

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Janice Alcaide

703-208-3771janice.alcaide@usoncology.com

Karina Castillo Grady

571-350-8758karina.castillogrady@usoncology.com

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Kim Reeves

206-337-3851kimberly.reeves@swedish.org

Anna Pannick

206-386-3142Anna.Pannick@Swedish.org

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Scott Tykodi, MD

stykodi@fredhutch.org

University of Wisconsin - Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

UW Cancer Connect

608-262-0439clinicaltrials@cancer.wisc.edu

More Information

Sponsor

HiberCell, Inc.

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

  • ccRCC
  • belzutifan
  • kidney cancer
  • metastatic
  • locally advanced
  • HC-7366
  • WELIREG™

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by HiberCell, Inc. on 2026-01-15.