Study of HC-7366 with Belzutifan for Kidney Cancer
This study is looking at a new combination of two drugs, HC-7366 and belzutifan (WELIREG™), for patients with advanced kidney cancer (renal cell carcinoma) that has a clear cell component. HC-7366 is a new drug that activates a specific protein called GCN2 kinase. Belzutifan is a drug that blocks another protein called HIF-2α. The main goal is to find the safest and most effective dose of these two drugs when given together. The study will enroll about 80 patients aged 18 or older who have locally advanced (inoperable) or metastatic clear cell kidney cancer. The study is currently recruiting patients.
- Study design
- This is a Phase 1b, open-label, multicenter study. It will enroll approximately 80 participants in different groups, including those receiving HC-7366 alone and those receiving the combination.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, determining the maximum tolerated dose, is measured at 30 months.
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A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma
At a glance
Conditions
NCT06234605
Where you'd take part
This study runs at 20 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cedars-Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Cleveland Clinic
Cleveland, Ohiostudy coordinator listed
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washingtonstudy coordinator listed
Recruiting
HealthPartners Cancer Research Center
Saint Paul, Minnesotastudy coordinator listed
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New Yorkstudy coordinator listed
Recruiting
Providence Cancer Institute
Portland, Oregonstudy coordinator listed
Recruiting
Rocky Mountain Cancer Centers, LLP
Lone Tree, Coloradostudy coordinator listed
Recruiting
SCRI Oncology Partners
Nashville, Tennesseestudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
What this trial measures
- Determination of MTD and RP2D (combination cohorts only)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