This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06234605
Recruitment Status : Recruiting
First Posted : January 31, 2024
Last Update Posted : May 1, 2024
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
HiberCell, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: HC-7366 Drug: Belzutifan Phase 1

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 (Inoperable) or Metastatic Renal Cell Carcinoma
Actual Study Start Date : April 29, 2024
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Belzutifan

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Monotherapy (Cohort 1)
Participants will receive HC-7366 monotherapy [dose to be determined] daily
 Drug: HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.
Experimental: Combination Escalation (Cohort 2)
Participants will receive HC-7366 20 mg plus belzutifan 120 mg daily
 Drug: HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.

Drug: Belzutifan
Belzutifan is a potent and selective HIF-2α inhibitor
Other Names:
  • WELIREG™
  • MK-6482
Experimental: Combination Escalation (Cohort 3)
Participants will receive HC-7366 40 mg plus belzutifan 120 mg daily
 Drug: HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.

Drug: Belzutifan
Belzutifan is a potent and selective HIF-2α inhibitor
Other Names:
  • WELIREG™
  • MK-6482
Experimental: Combination Escalation (Cohort 4)
Participants will receive HC-7366 75 mg plus belzutifan 120 mg daily
 Drug: HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.

Drug: Belzutifan
Belzutifan is a potent and selective HIF-2α inhibitor
Other Names:
  • WELIREG™
  • MK-6482
Experimental: Combination Expansion (Cohort 5)
Participants will receive HC-7366 [dose selected from escalation] plus belzutifan 120 mg daily
 Drug: HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.

Drug: Belzutifan
Belzutifan is a potent and selective HIF-2α inhibitor
Other Names:
  • WELIREG™
  • MK-6482
Experimental: Combination Expansion (Cohort 6)
Participants will receive HC-7366 [dose selected from escalation] plus belzutifan 120 mg daily
 Drug: HC-7366
HC-7366 is a novel, orally administered, highly selective and potent general control nonderepressible 2 (GCN2) kinase activator.

Drug: Belzutifan
Belzutifan is a potent and selective HIF-2α inhibitor
Other Names:
  • WELIREG™
  • MK-6482


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Determination of MTD and RP2D (combination cohorts only) [ Time Frame: Approximately 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

  2. Occurrence of dose limits toxicities in the dose-escalation period [ Time Frame: Approximately 30 months ]
  3. Number of participants who experience treatment-emergent adverse events (TEAEs) and treatment-related TEAEs and the severity of these events [ Time Frame: Approximately 30 months ]
  4. Number of participants who experience TEAEs leading to premature discontinuation [ Time Frame: Approximately 30 months ]
  5. Number of participants who experience laboratory abnormalities [ Time Frame: Approximately 30 months ]
  6. Number of participants who experience abnormalities observed in 12-lead ECG parameters. [ Time Frame: Approximately 30 months ]
  7. Number of participants who experience abnormalities observed in vital signs measurements. [ Time Frame: Approximately 30 months ]
    Number of participants who experience abnormalities observed in vital signs measurements.


Secondary Outcome Measures :
  1. Overall response rate (ORR): percentage of participants who achieved documented complete response (CR) + confirmed partial response (PR) per RECIST Version 1.1 [ Time Frame: Approximately 30 months ]
  2. Duration of response (DOR): time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first per RECIST Version 1.1 [ Time Frame: Approximately 30 months ]
  3. Time to response (TTR): time from first dose to first documented response [ Time Frame: Approximately 30 months ]
  4. Progression-free survival (PFS) and PFS at 6 months: time from first dose to documented disease progression or death due to any cause, whichever occurs first per RECIST Version 1.1 [ Time Frame: Approximately 30 months ]
  5. Median overall survival (OS) and 1-yr OS: time from the first day of study intervention to death due to any cause [ Time Frame: Approximately 30 months ]
  6. Area under the plasma concentration versus time curve from time 0 until the last measurable concentration (AUC 0-last [ng∙hr/mL]) [ Time Frame: Approximately 30 months ]
  7. Area under the plasma concentration versus time curve from time 0 to 24 hours (AUC 0-24 [ng∙hr/mL]) [ Time Frame: Approximately 30 months ]
  8. Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC 0-∞ [ng∙hr/mL]) [ Time Frame: Approximately 30 months ]
  9. Area under the plasma concentration versus time curve over a dosing interval (AUC 0-τ [ng∙hr/mL]) [ Time Frame: Approximately 30 months ]
  10. Maximum plasma concentration (Cmax [ng/mL]) [ Time Frame: Approximately 30 months ]
  11. Time of the maximum observed plasma concentration (tmax [hour]) [ Time Frame: Approximately 30 months ]
  12. Apparent total clearance (CL/F [L/h]) [ Time Frame: Approximately 30 months ]
  13. Apparent volume of distribution during the terminal phase (Vz/F [L]) [ Time Frame: Approximately 30 months ]
  14. Apparent terminal elimination half-life (t1/2 [h]) [ Time Frame: Approximately 30 months ]
  15. Accumulation ratio based on AUC0-τ (AR AUC) [ Time Frame: Approximately 30 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Patients with progressive disease after receipt of at least 2 and no more than 5 prior lines of therapy for metastatic (stage IV) disease, including but not limited to VEGF-directed tyrosine kinase inhibitors (TKIs), high-dose IL-2, immune checkpoint inhibitors, or Mtor inhibitors alone or in combination.
  • Has adequate organ function
  • Has ECOG performance score of 0-1
  • Has at least one measurable lesion as per RECIST 1.1.
  • Has a life expectancy of 3 months or greater as determined by the treating physician.

Exclusion Criteria:

  • Has received prior treatment with belzutifan or another HIF-2α inhibitor
  • Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) ≤2 weeks before allocation.
  • Has received any type of systemic anticancer antibody (including investigational antibody) ≤4 weeks before allocation.
  • Has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment
  • Has had history of major surgery < 3 weeks before allocation
  • Has received prior radiotherapy within 2 weeks before allocation
  • Have clinically significant cardiovascular disease within 6 months from first dose of study drug administration
  • Has known additional malignancy that is progressing or required active treatment within the past 5 years
  • Has a history of or known active central nervous system metastases and/or carcinomatous meningitis
  • Is unable to swallow orally administered medication intact or has a history or current evidence of a gastrointestinal disorder
  • Has known human immunodeficiency virus (HIV) and/or hepatitis B or C infections
  • Has a history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, or interfere with the individual's ability to cooperate with the requirements of the study
  • Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the screening visit through 90 days after the final administration of the study drug.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06234605


Contacts
Layout table for location contacts
Contact: HiberCell 651-675-0300 HC366-RCC2311_StudyMailbox@catalystcr.com

Locations
Layout table for location information
United States, California
University of California San Diego Moores Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Rana McKay         
United States, Colorado
Rocky Mountain Cancer Centers, LLP Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Manojkumar Bupathi         
United States, Minnesota
HealthPartners Cancer Research Center Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Brian Rank         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Joel Picus         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Neil Shah         
United States, Tennessee
SCRI Oncology Partners Recruiting
Nashville, Tennessee, United States, 37203
Contact: Benjamin Garmezy         
Sponsors and Collaborators
HiberCell, Inc.
Merck Sharp & Dohme LLC
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: HiberCell, Inc.
ClinicalTrials.gov Identifier: NCT06234605    
Other Study ID Numbers: HC366-RCC2311
MK-6482-030 ( Other Identifier: Merck Sharp & Dohme LLC )
First Posted: January 31, 2024    Key Record Dates
Last Update Posted: May 1, 2024
Last Verified: April 2024

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HiberCell, Inc.:
ccRCC
belzutifan
kidney cancer
metastatic
 locally advanced
HC-7366
WELIREG™
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
 Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Belzutifan
Antineoplastic Agents