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

RECRUITINGPhase 1Sponsored by HiberCell, Inc.
Actively Recruiting
PhasePhase 1
SponsorHiberCell, Inc.
Started2024-04-29
Est. completion2026-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations20 sites

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerRenal Cell Carcinoma

Locations20 sites

University of Arizona Cancer Center
Tucson, Arizona, 85719
Thomas Schlaback520-694-9090thomas2020@arizona.edu
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124

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