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NCT06234605PHASE1Recruiting

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

HiberCell, Inc.

Start Date

4/29/2024

Completion Date

11/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

HC-7366

DRUG

Belzutifan

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Conditions

Renal Cell Carcinoma

Locations

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