Safety of HRX215 in Patients After Minor and Major Liver Resection

The goal of this clinical trial is to learn if HRX215 is safe, tolerable and active in adults who have undergone liver resection due to colorectal carcinoma metastases. The objectives are: 1. to learn about the safety and tolerability of HRX215 2. to learn about how the body absorbs, distributes, and gets rid of HRX215. 3. to learn about clinical activity of HRX215 Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to investigate safety, tolerability and clinical activity in participants taking HRX215.

Trial Details

NCT ID
NCT06638502
Phase
PHASE1 / PHASE2
Sponsor
HepaRegeniX GmbH
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • HRX215 capsules
  • Placebo capsules
Locations (sample)
  • Baltimore, Maryland, United States|39.29038,-76.61219
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • Cleveland, Ohio, United States|41.4995,-81.69541
  • Lille, France|50.63391,3.05512
  • Villejuif, France|48.7939,2.35992

Key Eligibility Criteria

  • Participants with liver metastases originating from colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases
  • Part 1 only: stable participants within 1-3 days after minor liver resection, normal non-tumor liver parenchyma
  • Part 2 and 3 only: Major liver resection.
  • Low estimated risk for post-hepatectomy liver failure PHLF

For full eligibility, visit ClinicalTrials.gov.

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