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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.
Belzutifan is a potent and selective HIF-2α inhibitor
University of Arizona Cancer Center
Tucson, Arizona, United States
RECRUITINGUniversity of California San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGCedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGRocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, United States
RECRUITINGYale - New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGHealthPartners Cancer Research Center
Saint Paul, Minnesota, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGUniversity Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
RECRUITING...and 10 more locations
Determination of MTD and RP2D (combination cohorts only)
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
Time frame: 30 months
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