A Phase 1b Study of HC-7366 and Belzutifan in People With Advanced Kidney Cancer

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Full 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

Purpose

Researchers want to find the best dose of HC-7366 to use alone and with belzutifan in people with kidney cancer. The people in this study have advanced renal cell carcinoma (kidney cancer) that keeps growing after prior treatments. The cancer either cannot be removed (is inoperable) or has metastasized (spread). 

If you join this study, you will get either HC-7366 alone or with belzutifan. HC-7366 activates GCN2, an enzyme that plays a role in cancer cell growth and survival. Belzutifan is a standard treatment for kidney cancer. It blocks a protein called HIF-2-alpha, which plays a role in cancer growth. Both HC-7366 and belzutifan are taken by mouth.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have inoperable or metastatic renal cell carcinoma that keeps growing after at least 2 but no more than 5 prior regimens of therapy.
  • Have recovered from the serious side effects of treatment before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Neil Shah at 646-422-4468.

Protocol

24-061

Phase

Phase I (phase 1)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06234605