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Clinical Trials in the USA / NCT06234605
Recruiting Phase 1

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

NCT06234605 · tracked via the Priya Life Science USA tracker
Sponsor
HiberCell, Inc
Phase
Phase 1
Started
2024-04-29
Last updated
2026-10-02

Condition(s) studied

Renal Cell Carcinoma

Investigational drug(s) / intervention(s)

HC-7366Belzutifan →

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Determination of MTD and RP2D (combination cohorts only) — 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

Trial sites (21)

FacilityCityRegionStatus
University of Arizona Cancer Center Tucson Arizona Recruiting
University of California San Diego Moores Cancer Center La Jolla California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado Recruiting
Rocky Mountain Cancer Centers, LLP Lone Tree Colorado Recruiting
Yale - New Haven Hospital New Haven Connecticut Recruiting
Karmanos Cancer Institute Detroit Michigan Withdrawn
HealthPartners Cancer Research Center Saint Paul Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Providence Cancer Institute Portland Oregon Active Not Recruiting
Sarah Cannon Research Institute (SCRI) Nashville Tennessee Recruiting
Texas Oncology Dallas Texas Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
University Medical Center & Texas Tech Health Science Center Lubbock Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Recruiting
Swedish Medical Center Seattle Washington Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
University of Wisconsin - Carbone Cancer Center Madison Wisconsin Recruiting

Other trials for the same condition

A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV) Recruiting
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors Active, not recruiting
A Study of HFB200301 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors Active, not recruiting
Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies Active, not recruiting
A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06234605 on ClinicalTrials.gov ↗ ← All trials in the USA