Renal Cell Carcinoma
Conditions
Keywords
ccRCC, belzutifan, kidney cancer, metastatic, locally advanced, HC-7366, WELIREG™
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.
Interventions
DRUGHC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.
DRUGBelzutifan
Belzutifan is a potent and selective HIF-2α inhibitor
Sponsors
Merck Sharp & Dohme LLC
HiberCell, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactMichele Gargano
Backup ContactPaulette Mattson
Outcome results
None listed