Recruiting
Phase 1
Phase 2

HRX215

Sponsor:

HepaRegeniX GmbH

Code:

NCT06638502

Conditions

Liver Resection

Colorectal Carcinoma Liver Metastases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

HRX215 capsules

Placebo capsules

Study Details

Brief summary:

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.

Conditions

Liver Resection

Colorectal Carcinoma Liver Metastases

Study ID

NCT06638502

Start date

May 6, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active treatment minor hepatic resection

Pilot 1: 5 participants will receive HRX215 starting within 1-3 days after minor liver resection for colorectal liver metastases.

experimental: Active treatment major hepatic resection

Pilot 2: 10 participants will receive HRX215 starting treatment prior to major liver resection for colorectal liver metastases.

placebo comparator: Major hepatic resection (Randomized part control arm)

32 participants will receive placebo starting administration prior to major liver resection for colorectal liver metastases

experimental: Major hepatic resection (Randomized part)

32 participants will receive HRX215 starting administration prior to major liver resection for colorectal liver metastases.

Interventions

HRX215 capsules

HRX215 250 mg orally twice daily for a total treatment duration of 28 days

Placebo capsules

placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days

Primary outcome measure

  • Adverse Events (AEs) observed [ Time Frame: 6 months ]
  • HRX215 plasma levels [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Wolfgang Albrecht, PhD NC

+49 7071 7912809info@heparegenix.com

Linda Greenbaum, MD

484-343-2409l.greenbaum@heparegenix.com

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Christopher Shubert, MD

410-502-9207Christopher.shubert@jhu.edu

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Patrick Starlinger, M.D Ph.D.

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Michael Lidsky, MD

919-613-1474michael.lidsky@duke.edu

Principal Investigator:

Michael Lidsky, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Frederico Aucejo, MD

216-444-0537aucejof@ccf.org

More Information

Sponsor

HepaRegeniX GmbH

Last update posted

Sep 1, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by HepaRegeniX GmbH on 2026-09-01.