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Combination Escalation (Cohort 2) 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 approximately 30 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of MTD and RP2D (combination cohorts only)

Number of participants who experience TEAEs leading to premature discontinuation

Number of participants who experience abnormalities observed in 12-lead ECG parameters.

+4 more

Secondary outcome measures

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Monotherapy (Cohort 1)Experimental Treatment1 Intervention

Participants will receive HC-7366 monotherapy [dose to be determined] daily

Group II: Combination Expansion (Cohort 6)Experimental Treatment2 Interventions

Participants will receive HC-7366 [dose selected from escalation] plus belzutifan 120 mg daily

Group III: Combination Expansion (Cohort 5)Experimental Treatment2 Interventions

Participants will receive HC-7366 [dose selected from escalation] plus belzutifan 120 mg daily

Group IV: Combination Escalation (Cohort 4)Experimental Treatment2 Interventions

Participants will receive HC-7366 75 mg plus belzutifan 120 mg daily

Group V: Combination Escalation (Cohort 3)Experimental Treatment2 Interventions

Participants will receive HC-7366 40 mg plus belzutifan 120 mg daily

Group VI: Combination Escalation (Cohort 2)Experimental Treatment2 Interventions

Participants will receive HC-7366 20 mg plus belzutifan 120 mg daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belzutifan

2018

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,066 Total Patients Enrolled

HiberCell, Inc.Lead Sponsor

19 Previous Clinical Trials

800 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being included in this clinical trial?

"Affirmative. The information available on clinicaltrials.gov indicates that this investigation is actively seeking individuals to participate. Originally launched on March 1, 2024, and most recently revised on March 6, 2024, the trial aims to enroll a total of 80 patients at one designated location."

Answered by AI

Is this clinical trial currently open for enrollment?

"Affirmative. The details on clinicaltrials.gov reveal that this research study is currently seeking participants. Initially shared on March 1st, 2024, and most recently revised on March 6th, 2024, the trial aims to enroll 80 patients from a single site."

Answered by AI

Has the Combination Expansion (Cohort 6) received official approval from the FDA?

"Given that this is a Phase 1 trial with sparse safety and efficacy data, Combination Expansion (Cohort 6) has been rated as a level 1 in terms of safety by our team at Power."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of HC-7366 in Combination With Belzutifan (WELIREG™) in Patients With Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06234605.

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