HRX215 for Colorectal Liver Metastases

Overseen By Linda Greenbaum, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: HepaRegeniX GmbH

Disqualifiers: Liver cirrhosis, Ascites, Other liver cancer, others

Compensation: Varies

Number of Visits: 10

Duration: 28 days

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if HRX215 is safe and tolerable in adults who have undergone surgical removal of metastatic tumor(s) due to colorectal carcinoma in the liver. The main question it aims to answer are: 1. to learn about the safety of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215 . Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to see what medical problems participants have when taking HRX215. Participants will: Take HRX215 or a placebo twice a day for 28 days Daily visits for 7 days for checkups and tests which may either be in the hospital or outpatient after 3 days. Clinic visits every two weeks for the next two visits. The visit at two weeks may be a home visit or clinic visit. Additional clinic visits 3 months and 6 months after the start of treatment

Who Is on the Research Team?

Linda E Greenbaum, M.D.

Principal Investigator

HepaRegeniX GmbH

Patrick Starlinger, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who've had certain liver surgeries due to colon cancer spread. They must have a portion of their liver remaining (28%-50% for the main study, over 69% for the pilot phase) and normal liver function proven by recent tests.

Inclusion Criteria

My remaining liver volume is between 28% and 50%.

N/A

My liver surgery will leave more than 69% of my liver.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 days

Treatment

Participants receive HRX215 or placebo twice daily for 28 days

28 days

Daily visits for 7 days, then clinic visits every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Clinic visits at 3 and 6 months after treatment

What Are the Treatments Tested in This Trial?

Interventions

• HRX215

Trial Overview The trial is testing HRX215's safety after liver surgery in colorectal cancer patients. Participants will take HRX215 or placebo capsules twice daily for 28 days, with frequent checkups initially then every two weeks, followed by visits at 3 and 6 months.

How Is the Trial Designed?

Group I: Active treatment minor hepatic resection Experimental Treatment 1 Intervention

5 participants will receive HRX215 250 mg twice daily orally within 1-3 days after minor (\<=31%) liver resection for colorectal liver metastases for 28 days.

Group II: Active treatment arm major hepatic resection Active Control 1 Intervention

10 participants will receive HRX215 250 mg twice daily orally within 1-3 days after major (50-72%) liver resection for colorectal liver metastases for 28 days.

Group III: placebo arm major hepatic resection Placebo Group 1 Intervention

10 participants will receive placebo capsules with matching appearance to HRX215 twice daily orally within 1-3 days after major (50-72%) liver resection for colorectal liver metastases for 28 days

Who Is Running the Clinical Trial?

HepaRegeniX GmbH

Lead Sponsor

Trials

1

Recruited

30+