25 Participants Needed

HRX215 for Colorectal Liver Metastases

WA
LG
Overseen ByLinda Greenbaum, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: HepaRegeniX GmbH

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HRX215 (experimental treatment) to assess its safety and how the body processes it in individuals who have undergone surgery to remove colon cancer that spread to the liver. The study compares HRX215 to a placebo to identify any health issues participants might experience. It suits those who recently had surgery to remove liver tumors from colon cancer and have normal liver function otherwise. Participants will take the treatment or placebo twice daily for 28 days, with regular checkups and tests to monitor their health. As a Phase 1 trial, participants will be among the first to receive HRX215, aiding researchers in understanding how the treatment works in people.

Do I need to stop my current medications for the trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is examining HRX215 to determine its safety and tolerability in adults with liver cancer that has spread from the colon. Currently, limited information exists on responses to HRX215, as it remains in the early testing phase. At this stage, researchers focus primarily on understanding its safety.

The treatment targets individuals who have undergone liver surgery due to cancer spread. Early studies on similar treatments suggest that drugs like HRX215 might aid liver recovery post-surgery. This indicates HRX215 could potentially support liver healing, though its safety continues to be closely monitored.

Since HRX215 is in an early trial phase, its safety is not yet fully established. Researchers will closely monitor participants for any side effects or issues to ensure their well-being during the study.12345

Why do researchers think this study treatment might be promising for colorectal liver metastases?

Researchers are excited about HRX215 for colorectal liver metastases because it offers a potentially novel way to tackle cancer that has spread to the liver. Unlike the standard of care, which typically involves chemotherapy and surgical resection, HRX215 is an oral medication taken twice daily, making it potentially more convenient for patients. Additionally, HRX215 is being evaluated both after major and minor liver resections, providing flexibility in its application based on the extent of liver surgery. This approach could lead to new insights into how we can improve recovery and outcomes for patients undergoing liver resection due to colorectal cancer metastasis.

What evidence suggests that HRX215 might be an effective treatment for colorectal liver metastases?

Research has shown that HRX215 could be a promising treatment for cancer that has spread to the liver. In this trial, participants will receive either HRX215 or a placebo after liver resection surgeries. HRX215 aids in liver self-healing, which is beneficial after surgeries where part of the liver is removed. Studies have found that HRX215 speeds up liver recovery by blocking a specific protein. This may help prevent serious liver problems in patients who have had a large portion of their liver removed. Although still in early stages, these findings suggest that HRX215 could improve recovery after liver surgeries related to cancer.45678

Who Is on the Research Team?

LE

Linda E Greenbaum, M.D.

Principal Investigator

HepaRegeniX GmbH

PS

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?
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active treatment minor hepatic resectionExperimental Treatment1 Intervention
Group II: Active treatment arm major hepatic resectionActive Control1 Intervention
Group III: placebo arm major hepatic resectionPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

HepaRegeniX GmbH

Lead Sponsor

Trials
1
Recruited
30+

Citations

HRX215 for Colorectal Liver MetastasesThe 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 ...
Hepatic Metastasis of Colorectal Cancer (DBCOND0125015)Associated Data ; NCT06848842. Ivonescimab Plus Chemotherapy in Patients with Initially Unresectable Colorectal Cancer Liver Metastases. Ivonescimab ; NCT02331641.
Colorectal liver metastases: Current management and future ...For those resected patients, median overall survival was 45 (range, 36–60 mo) mo with 19% of patients alive and recurrence-free, thus comparing favourably to ...
HRX-215 - Drug Targets, Indications, PatentsThis study demonstrated that the first-in-class MKK4 inhibitor HRX215 showed a promising effect in pro- moting the rapid boost of liver regeneration with ...
First-in-class MKK4 inhibitors enhance liver regeneration ...In conclusion, these data suggest that the HRX215-mediated boost of liver regeneration effectively prevented a lethal PHLF upon 85% hepatectomy ...
Safety of HRX215 in Patients After Minor and Major Liver ...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 ...
HepaRegeniX starts dosing subjects in trial of HRX-215 in ...HepaRegeniX has begun dosing subjects in a Phase Ib trial of HRX-215 in subjects undergoing partial liver resection due to liver metastases.
Prometheus 2.0: drug-induced liver regeneration arisingThese patients suffer from hepatocyte loss, liver failure and impaired metabolic function causing toxic ammonia levels. Importantly, HRX215 ...
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