Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
completion around

Description

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.

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

Keywords

Renal Cell Carcinoma, ccRCC, belzutifan, kidney cancer, metastatic, locally advanced, HC-7366, WELIREG™, Carcinoma, Monotherapy

Eligibility

For people ages 18 years and up

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

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
HiberCell, Inc.
ID
NCT06234605
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated