A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma

Description

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.

Conditions

Renal Cell Carcinoma

Study Overview

Study Details

Study overview

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.

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

A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma

Condition
Renal Cell Carcinoma
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Arizona Cancer Center, Tucson, Arizona, United States, 85719

La Jolla

University of California San Diego Moores Cancer Center, La Jolla, California, United States, 92093

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Lone Tree

Rocky Mountain Cancer Centers, LLP, Lone Tree, Colorado, United States, 80124

Saint Paul

HealthPartners Cancer Research Center, Saint Paul, Minnesota, United States, 55101

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Portland

Providence Cancer Institute, Portland, Oregon, United States, 97213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

HiberCell, Inc.,

Study Record Dates

2027-11