Participate in Research at CU Anschutz

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.

This study plans to learn more about and identify the highest safe dose (called the maximum tolerated dose and/ or recommended dose) of the study drug HC-7366 and Belzutifan (also known as MK-6482) for the next phase of testing (called the recommended Phase 2 dose). The study aims to understand how well HC7366 and Belzutifan work together and how safe they are when given to patients with locally advanced metastatic Renal Cell Carcinoma (RCC) with predominantly clear cell histology, a specific type of kidney cancer. “Investigational” means the drug is not approved by the United States Food and Drug Administration (FDA). The term “study drug” or “study medication” will be used throughout this document to refer to HC-7366 capsules and/or belzutifan tablets. You are being asked to be in this research study because you have metastatic renal cell carcinoma (RCC) and you have gotten worse after treatment with at least one but no more than four previous chemotherapies or other therapy.