A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma - Trial NCT06234605
Access comprehensive clinical trial information for NCT06234605 through Pure Global AI's free database. This Phase 1 trial is sponsored by HiberCell, Inc. and is currently Recruiting. The study focuses on Renal Cell Carcinoma. Target enrollment is 80 participants.
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Study Focus
Sponsor & Location
HiberCell, Inc.
Timeline & Enrollment
Phase 1
Mar 01, 2024
Nov 01, 2027
Primary Outcome
Determination of MTD and RP2D (combination cohorts only),Occurrence of dose limits toxicities in the dose-escalation period,Number of participants who experience treatment-emergent adverse events (TEAEs) and treatment-related TEAEs and the severity of these events,Number of participants who experience TEAEs leading to premature discontinuation,Number of participants who experience laboratory abnormalities,Number of participants who experience abnormalities observed in 12-lead ECG parameters.,Number of participants who experience abnormalities observed in vital signs measurements.
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06234605
Non-Device Trial