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

Last updated: January 13, 2026
Sponsor: HiberCell, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Carcinoma

Neoplasm Metastasis

Urothelial Tract Cancer

Treatment

HC-7366

Belzutifan

Clinical Study ID

NCT06234605
HC366-RCC2311
MK-6482-030
  • Ages > 18
  • All Genders

Study 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

Inclusion

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

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: HC-7366
Phase: 1
Study Start date:
April 29, 2024
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • University of Arizona Cancer Center

    Tucson, Arizona 85719
    United States

    Site Not Available

  • University of Arizona Cancer Center

    Tucson 5318313, Arizona 5551752 85719
    United States

    Active - Recruiting

  • University of California San Diego Moores Cancer Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California San Diego Moores Cancer Center

    La Jolla 5363943, California 5332921 92093
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers, LLP

    Lone Tree, Colorado 80124
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora 5412347, Colorado 5417618 80045
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers, LLP

    Lone Tree 5429208, Colorado 5417618 80124
    United States

    Active - Recruiting

  • Yale - New Haven Hospital

    New Haven 4839366, Connecticut 4831725 06520
    United States

    Active - Recruiting

  • HealthPartners Cancer Research Center

    Saint Paul, Minnesota 55101
    United States

    Site Not Available

  • HealthPartners Cancer Research Center

    Saint Paul 5045360, Minnesota 5037779 55101
    United States

    Active - Recruiting

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

  • Providence Cancer Institute

    Portland, Oregon 97213
    United States

    Site Not Available

  • Providence Cancer Institute

    Portland 5746545, Oregon 5744337 97213
    United States

    Active - Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Texas Oncology

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Oncology

    Dallas 4684888, Texas 4736286 75246
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • University Medical Center & Texas Tech Health Science Center

    Lubbock 5525577, Texas 4736286 79430
    United States

    Active - Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

  • University of Wisconsin - Carbone Cancer Center

    Madison, Wisconsin 53705
    United States

    Site Not Available

  • University of Wisconsin - Carbone Cancer Center

    Madison 5261457, Wisconsin 5279468 53705
    United States

    Active - Recruiting

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