HRX215, A First Generation MKK4 Inhibitor Drug, for the Treatment of Patients With Colorectal Liver Metastasis After Undergoing a Portal Vein Embolization

StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 1, 2028 → Nov 1, 2028
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Record History

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  1. Notable Start date: Sep 1, 2026 to Dec 1, 2026
    • Primary and study completion pushed from Aug 1, 2028 to Nov 1, 2028
    • Eligibility criteria expanded, about 66 words
    • Secondary endpoints: details revised at 7 of 8 entries
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Minor Eligibility criteria revised
    • Secondary endpoints: details revised at 1 of 8 entries
    • Collaborator revised
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
1,024 trials monitored
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3,405 trials monitored
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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.
Trial Details
NCT Number NCT07612007
Lead Sponsor Mayo Clinic
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)
Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Resectable Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v8
Related terms Colorectal Neoplasms
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov