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NCT07612007 · ClinicalTrials.gov registry record · Phase 2
HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization
A Phase 2 study, sponsored by Mayo Clinic.
- Not yet
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT07612007: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT07612007 is a Phase 2 study that has not yet begun recruiting, run by Mayo Clinic. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07612007, a Phase 2 study, has not yet begun recruiting, sponsored by Mayo Clinic.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This phase IIb trial tests the effect of HRX215 in treating patients with colorectal cancer that has spread from where it first started to the liver (liver metastasis) after undergoing a portal vein embolization (PVE). Currently, surgery to remove the tumor (hepatectomy) remains the only potential treatment for cure. However, less than 30% of patients are considered resectable (can be removed by surgery) at the time of diagnosis. The risk of liver failure and other complications rise with larger areas liver that is removed during surgery. Therefore, the potential for surgery is determined by the amount of liver that will remain after resection. PVE is a standard strategy to increase the potential for resection. A PVE is a procedure that blocks the portal vein (a blood vessel that carries blood to the liver) to prevent flow of blood to the tumor. HRX215 targets and binds to MKK4, a protein found on liver cells plays a part in cellular growth and prevents liver repair and regrowth of cells and tissue. Blocking the activity of MKK4 may help prevent liver failure, protect liver cells and improve liver mass. Giving HRX215 after a PVE may help improve the rate of liver regrowth and increase the likelihood of hepatectomy in patients with colorectal liver metastasis.
Primary Outcome
Will be defined as the percentage of the liver expected to remain after a planned hepatectomy. Will be compared between the two treatment groups \[HRX215 versus (vs) placebo\] utilizing an analysis of covariance (ANCOVA) F-test controlling for age, gender, and FLR at baseline.
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- DRUG Embolization Therapy
- DRUG Darizmetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2028-08-01 |
| Phase | Phase 2 |
What is known before NCT07612007 opens enrollment
NCT07612007 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT07612007 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07612007 about?
NCT07612007 is a clinical study titled "HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization". This phase IIb trial tests the effect of HRX215 in treating patients with colorectal cancer that has spread from where it first started to the liver (liver metastasis) after undergoing a portal vein embolization (PVE). Currently, surgery to remove the tumor (hepatectomy) remains the only potential t...
What is the current status of trial NCT07612007?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2026-09-01. Estimated completion is 2028-08-01.
What interventions are being tested in trial NCT07612007?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Embolization Therapy (DRUG), Darizmetinib (DRUG).
Who is sponsoring clinical trial NCT07612007?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07612007's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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