RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-29
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06234605

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Has diagnosis of locally advanced (inoperable) or metastatic RCC with a predominant clear cell component
  2. * Be age 18 years or older (male or female) at the time of consent
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Megan Holm
CONTACT
651-675-0300
mholm@hibercell.com
Paulette Mattson
CONTACT
651-675-0300
pmattson@hibercell.com

Study Locations (Sites)

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
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, 55101
United States
Washington University School of Medicine
Saint 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
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Swedish Medical Center
Seattle, Washington, 98104
United States
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: HiberCell, Inc.

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 Registration Dates

Study Start Date2024-04-29
Study Completion Date2027-11

Study Record Updates

Study Start Date2024-04-29
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • ccRCC
  • belzutifan
  • kidney cancer
  • metastatic
  • locally advanced
  • HC-7366
  • WELIREG™

Additional Relevant MeSH Terms

  • Renal Cell Carcinoma