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.
Participation Requirements• 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
University of Arizona Cancer Center
RECRUITING
Tucson
University of California San Diego Moores Cancer Center
RECRUITING
La Jolla
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Rocky Mountain Cancer Centers, LLP
RECRUITING
Lone Tree
HealthPartners Cancer Research Center
RECRUITING
Saint Paul
Washington University School of Medicine
RECRUITING
St Louis
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Cleveland Clinic
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Providence Cancer Institute
RECRUITING
Portland
SCRI Oncology Partners
RECRUITING
Nashville
Texas Oncology
RECRUITING
Dallas
Virginia Cancer Specialists
RECRUITING
Fairfax
Swedish Medical Center
RECRUITING
Seattle
University of Wisconsin - Carbone Cancer Center
RECRUITING
Madison
Primary
Megan Holm
mholm@hibercell.com
651-675-0300
Backup
Paulette Mattson
pmattson@hibercell.com
651-675-0300
Start Date: 2024-04-29
Estimated Completion Date: 2027-11
Target number of participants: 80
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
Collaborators: Merck Sharp & Dohme LLC