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

NCT ID: NCT06234605

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-29

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy

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

Group Type EXPERIMENTAL

HC-7366

Intervention Type DRUG

HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.

Combination

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

Group Type EXPERIMENTAL

HC-7366

Intervention Type DRUG

HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.

Belzutifan

Intervention Type DRUG

Belzutifan is a potent and selective HIF-2α inhibitor

Interventions

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HC-7366

HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.

Intervention Type DRUG

Belzutifan

Belzutifan is a potent and selective HIF-2α inhibitor

Intervention Type DRUG

Other Intervention Names

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WELIREG™ MK-6482

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

HiberCell, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status RECRUITING

University of California San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers, LLP

Lone Tree, Colorado, United States

Site Status RECRUITING

Yale - New Haven Hospital

New Haven, Connecticut, United States

Site Status RECRUITING

HealthPartners Cancer Research Center

Saint Paul, Minnesota, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

Cleveland Clinic

Cleveland, Ohio, United States

Site Status RECRUITING

Providence Cancer Institute

Portland, Oregon, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

Texas Oncology

Dallas, Texas, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

University Medical Center & Texas Tech Health Science Center

Lubbock, Texas, United States

Site Status RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status RECRUITING

Swedish Medical Center

Seattle, Washington, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status RECRUITING

University of Wisconsin - Carbone Cancer Center

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michele Gargano

Role: CONTACT

651-675-0300

Paulette Mattson

Role: CONTACT

651-675-0300

Facility Contacts

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Thomas Schlaback

Role: primary

520-694-9090

Cindie Neal

Role: backup

520-626-6954

Karen Cuervo

Role: primary

Linda Ford

Role: primary

Elaine Lam, MD

Role: primary

Bobbie Donnachaidh

Role: primary

Jennifer Hege

Role: backup

David Schoenfeld, MD

Role: primary

Octav Pacurar

Role: primary

Joel Picus

Role: primary

Rachel Jacobi

Role: primary

Kathryn Helminiak

Role: primary

David Lynn

Role: primary

Katrina Herz

Role: primary

Emma Brennan

Role: primary

Lauren King

Role: backup

Lisa Jones

Role: primary

Hans Hammers, MD

Role: primary

Thomas Hutson, MD

Role: primary

Janice Alcaide

Role: primary

703-208-3771

Karina Castillo Grady

Role: backup

571-350-8758

Kim Reeves

Role: primary

206-337-3851

Anna Pannick

Role: backup

206-386-3142

Scott Tykodi, MD

Role: primary

UW Cancer Connect

Role: primary

608-262-0439

Other Identifiers

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MK-6482-030

Identifier Type: OTHER

Identifier Source: secondary_id

HC366-RCC2311

Identifier Type: -

Identifier Source: org_study_id

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