Renal Cell Carcinoma Clinical Trial
Official title:
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
| Verified date | June 2024 |
| Source | HiberCell, Inc. |
| Contact | Megan Holm |
| Phone | 651-675-0300 |
| mholm[@]hibercell.com | |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | November 2027 |
| Est. primary completion date | November 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | University Hospitals Cleveland Medical Center | Cleveland | Ohio |
| United States | Texas Oncology | Dallas | Texas |
| United States | University of California San Diego Moores Cancer Center | La Jolla | California |
| United States | Rocky Mountain Cancer Centers, LLP | Lone Tree | Colorado |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | SCRI Oncology Partners | Nashville | Tennessee |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Providence Cancer Institute | Portland | Oregon |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | HealthPartners Cancer Research Center | Saint Paul | Minnesota |
| Lead Sponsor | Collaborator |
|---|---|
| HiberCell, Inc. | Merck Sharp & Dohme LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 30 months |
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