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

January 13, 2026 updated by: HiberCell, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego Moores Cancer Center
        • Contact:
      • Los Angeles, California, United States, 90048
    • Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
          • Joel Picus
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44106
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97213
    • Tennessee
    • Texas
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75246
      • Lubbock, Texas, United States, 79430
        • Recruiting
        • University Medical Center & Texas Tech Health Science Center
        • Contact:
    • Virginia
    • Washington
      • Seattle, Washington, United States, 98109
      • Seattle, Washington, United States, 98104
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin - Carbone Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy
Participants will receive HC-7366 monotherapy [dose to be determined] daily
Drug: HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.
Experimental: Combination
Participants will receive HC-7366 monotherapy [dose to be determined] in combination with belzutifan [120 mg] daily
Drug: HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.
Drug: Belzutifan
Belzutifan is a potent and selective HIF-2α inhibitor
Other Names:
  • MK-6482
  • WELIREG™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of MTD and RP2D (combination cohorts only)
Time Frame: 30 months
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall response rate (ORR): percentage of participants who achieved documented complete response (CR) + confirmed partial response (PR) per RECIST Version 1.1
Time Frame: Approximately 30 months
Approximately 30 months
Duration of response (DOR): time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first per RECIST Version 1.1
Time Frame: Approximately 30 months
Approximately 30 months
Time to response (TTR): time from first dose to first documented response
Time Frame: Approximately 30 months
Approximately 30 months
Progression-free survival (PFS) and PFS at 6 months: time from first dose to documented disease progression or death due to any cause, whichever occurs first per RECIST Version 1.1
Time Frame: Approximately 30 months
Approximately 30 months
Median overall survival (OS) and 1-yr OS: time from the first day of study intervention to death due to any cause
Time Frame: Approximately 30 months
Approximately 30 months
Area under the plasma concentration versus time curve from time 0 until the last measurable concentration (AUC 0-last [ng∙hr/mL])
Time Frame: Approximately 30 months
Approximately 30 months
Area under the plasma concentration versus time curve from time 0 to 24 hours (AUC 0-24 [ng∙hr/mL])
Time Frame: Approximately 30 months
Approximately 30 months
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC 0-∞ [ng∙hr/mL])
Time Frame: Approximately 30 months
Approximately 30 months
Area under the plasma concentration versus time curve over a dosing interval (AUC 0-τ [ng∙hr/mL])
Time Frame: Approximately 30 months
Approximately 30 months
Maximum plasma concentration (Cmax [ng/mL])
Time Frame: Approximately 30 months
Approximately 30 months
Time of the maximum observed plasma concentration (tmax [hour])
Time Frame: Approximately 30 months
Approximately 30 months
Apparent total clearance (CL/F [L/h])
Time Frame: Approximately 30 months
Approximately 30 months
Apparent volume of distribution during the terminal phase (Vz/F [L])
Time Frame: Approximately 30 months
Approximately 30 months
Apparent terminal elimination half-life (t1/2 [h])
Time Frame: Approximately 30 months
Approximately 30 months
Accumulation ratio based on AUC0-τ (AR AUC)
Time Frame: Approximately 30 months
Approximately 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HiberCell, Inc.

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

January 31, 2024

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC366-RCC2311
  • MK-6482-030 (Other Identifier: Merck Sharp & Dohme LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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