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HC-7366 + Belzutifan for Kidney Cancer

Phase 1
Recruiting
Research Sponsored by HiberCell, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, HC-7366, in combination with belzutifan to see how safe and effective it is in treating patients with advanced kidney cancer. They will enroll

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects aren't listed here but generally could include typical reactions seen with cancer medications such as nausea, fatigue, liver issues or changes in blood counts which will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determination of MTD and RP2D (combination cohorts only)
Secondary study objectives
Accumulation ratio based on AUC0-τ (AR AUC)
Apparent terminal elimination half-life (t1/2 [h])
Apparent total clearance (CL/F [L/h])
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belzutifan
2018
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,341 Total Patients Enrolled
HiberCell, Inc.Lead Sponsor
19 Previous Clinical Trials
800 Total Patients Enrolled
~53 spots leftby Nov 2026
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