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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07612007
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Colorectal Carcinoma
  • Metastatic Malignant Neoplasm in the Liver
  • Resectable Colorectal Carcinoma
  • Stage IV Colorectal Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tissue biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT and CT-PET
  • Darizmetinib — DRUG
    Given PO
  • Embolization Therapy — DRUG
    Undergo PVE
  • Hepatectomy — PROCEDURE
    Undergo hepatectomy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Placebo Administration — DRUG
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo CT-PET

Study Details

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.

Key Dates

Start date
Sep 1, 2026
Status verified
May 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (HRX215, PVE, hepatectomy)
    Patients undergo scheduled PVE on day 0. Starting 2 hours before undergoing PVE, patients receive HRX215 PO BID (orally twice daily) on days 0-27 in the absence of disease progression or unacceptable toxicity. Starting on or after day 32, patients may undergo scheduled hepatectomy. Patients also undergo blood sample collection, CT, MRI, and CT-PET throughout the study. Additionally, patients may undergo tissue biopsy during scheduled hepatectomy on study.
  • Placebo Comparator: Arm II (placebo, PVE, hepatectomy)
    Patients undergo scheduled PVE on day 0. Starting 2 hours before undergoing PVE, patients receive placebo PO BID (orally twice daily) on days 0-27 in the absence of disease progression or unacceptable toxicity. Starting on or after day 32, patients may undergo scheduled hepatectomy. Patients also undergo blood sample collection, CT, MRI, and CT-PET throughout the study. Additionally, patients may undergo tissue biopsy during scheduled hepatectomy on study.

Primary Outcome Measure

Future liver remnant size (FLR) [ Time Frame: At day 28 post-baseline ]

Central Contacts

  • Clinical Trials Referral Office
    855-776-0015
    [email protected]
  • Cancer Center Clinical Trials Referral Office
    507-293-6386

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Cancer Center Clinical Trials Referral Office
507-293-6386
Scott L. Nyberg, MD, PhD (PRINCIPAL_INVESTIGATOR)

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