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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
University of Arizona Cancer Center
RECRUITING
Tucson
California
University of California San Diego Moores Cancer Center
RECRUITING
La Jolla
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Colorado
Rocky Mountain Cancer Centers, LLP
RECRUITING
Lone Tree
Minnesota
HealthPartners Cancer Research Center
RECRUITING
Saint Paul
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Oregon
Providence Cancer Institute
RECRUITING
Portland
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
Texas Oncology
RECRUITING
Dallas
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Washington
Swedish Medical Center
RECRUITING
Seattle
Wisconsin
University of Wisconsin - Carbone Cancer Center
RECRUITING
Madison
Contact Information
Primary
Megan Holm
mholm@hibercell.com
651-675-0300
Backup
Paulette Mattson
pmattson@hibercell.com
651-675-0300
Time Frame
Start Date: 2024-04-29
Estimated Completion Date: 2027-11
Participants
Target number of participants: 80
Treatments
Experimental: Monotherapy
Participants will receive HC-7366 monotherapy \[dose to be determined\] daily
Experimental: Combination
Participants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: HiberCell, Inc.

This content was sourced from clinicaltrials.gov

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