A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell C
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
| Condition(s) | Renal Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | HiberCell, Inc. |
| Locations | Tucson, Arizona, United States; La Jolla, California, United States; Los Angeles, California, United States; Aurora, Colorado, United States; Lone Tree, Colorado, United States; New Haven, Connecticut, United States (+14 more sites) |
| Start date | 2024-04-29 |
| NCT ID | NCT06234605 |
| Official listing | https://clinicaltrials.gov/study/NCT06234605 |