An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
Trial Status: active
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.
Inclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT06234605.