RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

Safety of HRX215 in Patients After Minor and Major Liver Resection

Sponsor: HepaRegeniX GmbH • ClinicalTrials.gov ID: NCT06638502

Registry updated: 2026-09-14

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Description

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.

Interventions

HRX215 capsules (Drug)
HRX215 250 mg orally twice daily for a total treatment duration of 28 days
Placebo capsules (Drug)
placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days

Eligibility criteria

Inclusion 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 Further inclusion criteria apply Exclusion Criteria: * Liver Cirrhosis * Preoperative presence of clinical ascites * Any other hepatobiliary cancer * BMI \>35 kg/m2 * ASA Score \>4 * Peritoneal carcinomatosis Further exclusion criteria apply

Conditions

Liver Resection Colorectal Carcinoma Liver Metastases

Locations

Johns Hopkins Hospital — Baltimore, Maryland, United States
Mayo Clinic — Rochester, Minnesota, United States
Duke Cancer Institute — Durham, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Centre Hospitalier Régional Universitaire de Lille (CHRU) Hôpital Claude Huriez — Lille, France
Hôpital Paul-Brousse - Centre Hepato-Biliaire (CHB) — Villejuif, France
Universitatsklinikum Essen — Essen, Germany
Univ. Tuebingen - Universitaetsklinik fuer Allgemeine, Viszeral- und Transplantationschirurgie — Tübingen, Germany
Rabin Medical Center — Petah Tikva, Israel
Sheba Medical Center — Ramat Gan, Israel
Tel-Aviv Sourasky MC — Tel Aviv, Israel
Hospital Universitario La Paz — Madrid, Spain
South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro — Madrid, Spain
Consorci Hospital General Universitari de València — Valencia, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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