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A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
NCT06234605 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06234605
The ClinicalTrials.gov registry entry for NCT06234605 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HiberCell, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06234605 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Texas, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06234605?
The interventions under investigation include: Belzutifan (DRUG), HC-7366 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06234605?
This trial is sponsored by HiberCell, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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