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 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.

NCT Number	NCT07612007
Lead Sponsor	Mayo Clinic Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions	Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Resectable Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8
Enrollment	80 participants
Start Date	2026-09-01
Primary Completion	2028-08-01 (estimated)
Study Completion	2028-08-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-12