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NCT06234605 · ClinicalTrials.gov registry record · Phase 1
A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
A Phase 1 study of Renal Cell Carcinoma, sponsored by HiberCell.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT06234605: Recruiting Phase 1 study of Renal Cell Carcinoma, sponsored by HiberCell.
NCT06234605 is a Phase 1 study of Renal Cell Carcinoma that is actively recruiting participants, run by HiberCell. The registered enrollment target is 80 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06234605, a Phase 1 study of Renal Cell Carcinoma, is actively recruiting participants, sponsored by HiberCell.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
To identify the maximum tolerated dose (MTD) and/ or recommended Phase 2 dose (RP2D), and evaluate the safety, tolerability and dose-limiting toxicities (DLTs) 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 Studied
Interventions
- DRUG Belzutifan
- DRUG HC-7366
Study Locations (20)
Texas
- Texas Oncology - Dallas
- University of Texas Southwestern Medical Center - Dallas
- University Medical Center & Texas Tech Health Science Center - Lubbock
California
- University of California San Diego Moores Cancer Center - La Jolla
- Cedars-Sinai Medical Center - Los Angeles
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
- Rocky Mountain Cancer Centers, LLP - Lone Tree
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
- Cleveland Clinic - Cleveland
Washington
- Swedish Medical Center - Seattle
- Fred Hutchinson Cancer Center - Seattle
Arizona
- University of Arizona Cancer Center - Tucson
Connecticut
- Yale - New Haven Hospital - New Haven
Minnesota
- HealthPartners Cancer Research Center - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-04-29 |
| Est. Completion | 2027-11 |
| Phase | Phase 1 |
What NCT06234605 shows while recruiting
NCT06234605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Belzutifan is the first listed.
NCT06234605 names 20 study sites across 14 states, led by Texas, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06234605 about?
NCT06234605 is a clinical study titled "A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma". 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 patien...
What is the current status of trial NCT06234605?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2024-04-29. Estimated completion is 2027-11.
What conditions does trial NCT06234605 study?
This clinical trial studies the following conditions: Renal Cell Carcinoma.
What interventions are being tested in trial NCT06234605?
The interventions under investigation include: Belzutifan (DRUG), HC-7366 (DRUG).
Who is sponsoring clinical trial NCT06234605?
This trial is sponsored by HiberCell, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06234605 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06234605's enrollment target sits among peer trials
80 61st of 121 higher than 61 of 121 other Renal Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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