80 Participants Needed

HC-7366 + Belzutifan for Kidney Cancer

Recruiting at 14 trial locations
H
MH
TJ
PM
Overseen ByPaulette Mattson
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: HiberCell, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug HC-7366 + Belzutifan unique for kidney cancer treatment?

The drug combination of HC-7366 and Belzutifan is unique because Belzutifan is a small molecule inhibitor that targets hypoxia-inducible factor-2α (HIF-2α), which is involved in the growth of kidney cancer cells. This approach is different from traditional treatments as it specifically targets a pathway that is often active in kidney cancer, offering a new option for patients who have progressed after other therapies.12345

What data supports the effectiveness of the drug Belzutifan for kidney cancer?

Belzutifan has shown promising results in treating advanced clear cell renal cell carcinoma, both alone and in combination with other drugs, by inhibiting a protein that helps cancer cells grow. In studies, it demonstrated anti-tumor activity and was well tolerated, suggesting it could be an effective treatment option for this type of kidney cancer.13456

Are You a Good Fit for This Trial?

This trial is for adults with advanced kidney cancer that can't be removed by surgery or has spread, and who have tried other treatments (up to five lines) without success. They should be relatively healthy otherwise, able to perform daily activities with ease, and expected to live at least three more months.

Inclusion Criteria

My organs are functioning well.
I've had 2-5 treatments for stage IV cancer, including specific drug types.
Has at least one measurable lesion as per RECIST 1.1
See 3 more

Exclusion Criteria

I haven't had cancer treatment with antibodies in the last 4 weeks.
I had major surgery less than 3 weeks ago.
I have another cancer that has worsened or needed treatment in the last 5 years.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

HC-7366 Monotherapy

Participants receive HC-7366 monotherapy to determine the maximum tolerated dose

Duration not specified

Combination Dose Escalation

Participants receive HC-7366 in combination with belzutifan to determine the maximum tolerated dose

Duration not specified

Combination Dose Expansion

Participants receive the determined dose of HC-7366 in combination with belzutifan to further evaluate safety and efficacy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Belzutifan
  • HC-7366
Trial Overview The study tests HC-7366 alone and combined with Belzutifan in patients. It's designed in parts: first testing HC-7366 solo, then finding the safest high dose when used together, followed by a larger group trying this combo. The goal is to see how well these drugs work against kidney cancer.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: MonotherapyExperimental Treatment1 Intervention
Participants will receive HC-7366 monotherapy \[dose to be determined\] daily
Group II: CombinationExperimental Treatment2 Interventions
Participants will receive HC-7366 monotherapy \[dose to be determined\] in combination with belzutifan \[120 mg\] daily

Belzutifan is already approved in United States for the following indications:

🇺🇸
Approved in United States as Welireg for:
  • Advanced renal cell carcinoma (RCC) following a PD-1 or PD-L1 inhibitor and a VEGF TKI
  • Von Hippel-Lindau disease-associated RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors

Find a Clinic Near You

Who Is Running the Clinical Trial?

HiberCell, Inc.

Lead Sponsor

Trials
20
Recruited
860+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

The HIF-2α inhibitor, belzutifan, has shown effectiveness in treating advanced clear-cell renal cell carcinoma in the LITESPARK-005 and -003 trials, both as a standalone treatment and in combination with VEGFR tyrosine kinase inhibitors.
These promising results suggest that belzutifan could be used more broadly in cancer treatment, potentially extending its application beyond just von Hippel-Lindau disease-associated cancers.
Expanding "Practice-Changing" Belzutifan's Reach in RCC.[2023]
In a phase 2 study involving 52 patients with advanced clear cell renal cell carcinoma who had previously received immunotherapy, the combination of belzutifan and cabozantinib showed promising antitumour activity, with 30.8% of patients achieving a confirmed objective response, including one complete response.
The treatment was associated with manageable safety concerns, primarily hypertension (27% of patients), and serious treatment-related adverse events occurred in 29% of patients, indicating that while the combination therapy is effective, careful monitoring for side effects is necessary.
Belzutifan plus cabozantinib for patients with advanced clear cell renal cell carcinoma previously treated with immunotherapy: an open-label, single-arm, phase 2 study.Choueiri, TK., McDermott, DF., Merchan, J., et al.[2023]
In a phase 1 study involving 98 patients with advanced solid tumors and clear cell renal cell carcinoma (ccRCC), belzutifan (MK-6482) was found to be well tolerated, with no dose-limiting toxicities at doses up to 160 mg, establishing a recommended phase 2 dose of 120 mg once daily.
Belzutifan demonstrated preliminary anti-tumor activity in ccRCC, with a 25% objective response rate and a median progression-free survival of 14.5 months, indicating its potential as an effective treatment option for patients with this type of cancer.
Inhibition of hypoxia-inducible factor-2α in renal cell carcinoma with belzutifan: a phase 1 trial and biomarker analysis.Choueiri, TK., Bauer, TM., Papadopoulos, KP., et al.[2022]

Citations

Expanding "Practice-Changing" Belzutifan's Reach in RCC. [2023]
Belzutifan plus cabozantinib for patients with advanced clear cell renal cell carcinoma previously treated with immunotherapy: an open-label, single-arm, phase 2 study. [2023]
Inhibition of hypoxia-inducible factor-2α in renal cell carcinoma with belzutifan: a phase 1 trial and biomarker analysis. [2022]
LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy. [2023]
Belzutifan: First Approval. [2022]
Targeting hypoxia-inducible factor pathways in sporadic and Von Hippel-Lindau syndrome-related kidney cancers. [2022]
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