Renal Cell CarcinomaPhase 1NCT06234605
A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
A Phase 1 study testing HC-7366 and Belzutifan in people with Renal Cell Carcinoma, run by HiberCell, Inc. at 21 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- HC-7366 and Belzutifan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 21 sitesUnited States
- Study dates
- 29 Apr 2024to Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites, 19 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Elaine Lam, MD, elaine.lam@cuanschutz.edu
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Gina Wick, Gina.Wick@UHhospitals.org
Lindsay Spiker, Lindsay.Spiker@uhhospitals.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Christina Dempsey, DEMPSEC2@ccf.org
Ireland Flores Rae, floresi@ccf.org
- Recruiting
Texas Oncology
Dallas, Texas, 75246
Sarah Shipley, sarah.shipley@usoncology.com
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Hans Hammers, MD, Hans.Hammers@utsouthwestern.edu
Jennnifer Bloxham, Jennifer.Bloxham@utsouthwestern.edu
- Withdrawn
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Nicolas Rojas, Nicolas.Rojas2@usoncology.com
Karina Castillo Grady, 571-350-8758, karina.castillogrady@usoncology.com
- Recruiting
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
Karen Cuervo, kcuervo@health.ucsd.edu
- Recruiting
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
Annie Sauve, Annie.Sauve@usoncology.com
Jennifer Hege, jennifer.hege@usoncology.com
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Allison Bautista, Allison.Bautista@cshs.org
- Recruiting
University Medical Center & Texas Tech Health Science Center
Lubbock, Texas, 79430
Mariana Fiori, Mariana.Fiori@ttuhsc.edu
- Recruiting
University of Wisconsin - Carbone Cancer Center
Madison, Wisconsin, 53705
Ellie Dahms, edahms@wisc.edu
- Recruiting
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, 37203
Amber Cox, Amber.Cox@scri.com
Alexis Daniel, alexis.daniel@scri.com
- Recruiting
Yale - New Haven Hospital
New Haven, Connecticut, 06520
David Schoenfeld, MD, david.schoenfeld@yale.edu
Chioma Amenechi, chioma.amenechi@yale.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Kira vom Eigen, vomeigek@mskcc.org
- Active, not recruiting
Providence Cancer Institute
Portland, Oregon, 97213
- Recruiting
HealthPartners Cancer Research Center
Saint Paul, Minnesota, 55101
Octav Pacurar, Octav.Pacurar@ParkNicollet.com
- Recruiting
Swedish Medical Center
Seattle, Washington, 98104
Kallie Sorenson, Kallie.Sorenson@Swedish.org
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Scott Tykodi, MD, stykodi@fredhutch.org
Jennifer Hanneld Cooper, jhcooper@fredhutch.org
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Melissa Reimers, MD, mreimers@wustl.edu
Jessica Klette, j.klette@wustl.edu
- Recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85719
Luis Rivera, Lrivera2@arizona.edu
About this study
Official title: 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
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
- Being tested
- HC-7366, Belzutifan
- Keywords
- ccRCC, belzutifan, kidney cancer, metastatic, locally advanced, HC-7366, WELIREG™
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC-7366Drug
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.
BelzutifanDrug
Also called WELIREG™, MK-6482
Belzutifan is a potent and selective HIF-2α inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy | Experimental | Participants will receive HC-7366 monotherapy [dose to be determined] daily Receives: Drug: HC-7366 |
| Combination | Experimental | Participants will receive HC-7366 monotherapy [dose to be determined] in combination with belzutifan [120 mg] daily Receives: Drug: HC-7366; Drug: Belzutifan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of MTD and RP2D (combination cohorts only)
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
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start29 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HiberCell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06234605
- Sponsor's protocol ID
- HC366-RCC2311
- Other IDs
- MK-6482-030
- Status last verified
- Sep 2026
- First submitted
- 9 Jan 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06234605
- Acronym / sponsor ID
- HC366-RCC2311
- Conditions
- Renal Cell Carcinoma
- Keywords
- ccRCC, belzutifan, kidney cancer, metastatic, locally advanced, HC-7366, WELIREG™
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HiberCell, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy | Experimental | Drug: HC-7366Participants will receive HC-7366 monotherapy [dose to be determined] daily |
| Combination | Experimental | Drug: HC-7366, Drug: BelzutifanParticipants will receive HC-7366 monotherapy [dose to be determined] in combination with belzutifan [120 mg] daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC-7366HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator. | Drug | Combination, Monotherapy |
| BelzutifanAlso: WELIREG™, MK-6482Belzutifan is a potent and selective HIF-2α inhibitor | Drug | Combination |
Primary outcome
Determination of MTD and RP2D (combination cohorts only)
Time frame: 30 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HC-7366 and Belzutifan in people with Renal Cell Carcinoma, run by HiberCell, Inc. at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Gargano (651-675-0300, mgargano@hibercell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of MTD and RP2D (combination cohorts only) (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.