A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
- Registration Number
- NCT06234605
- Lead Sponsor
- HiberCell, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Combination HC-7366 Participants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily Combination Belzutifan Participants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily Monotherapy HC-7366 Participants will receive HC-7366 monotherapy \[dose to be determined\] daily
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
University of California San Diego Moores Cancer Center
🇺🇸La Jolla, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Rocky Mountain Cancer Centers, LLP
🇺🇸Lone Tree, Colorado, United States
HealthPartners Cancer Research Center
🇺🇸Saint Paul, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Providence Cancer Institute
🇺🇸Portland, Oregon, United States
SCRI Oncology Partners
🇺🇸Nashville, Tennessee, United States
Texas Oncology
🇺🇸Dallas, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
University of Wisconsin - Carbone Cancer Center
🇺🇸Madison, Wisconsin, United States