NCT06638502

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. 1.to learn about the safety and tolerability of HRX215
  2. 2.to learn about how the body absorbs, distributes, and gets rid of HRX215.
  3. 3.to learn about clinical activity of HRX215

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
20mo left

Started May 2025

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
May 2025Dec 2027

First Submitted

Initial submission to the registry

October 9, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

May 6, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

October 9, 2024

Last Update Submit

April 15, 2026

Conditions

Liver ResectionColorectal Carcinoma Liver Metastases

Outcome Measures

Primary Outcomes (2)

  • Adverse Events (AEs) observed

    Incidence, severity, and relatedness of AEs/SAEs. Changes in vital signs and physical examination findings. Clinical laboratory investigation.

    6 months

  • HRX215 plasma levels

    Levels of drug (HRX215) at selected time intervals after drug administration

    28 days

Secondary Outcomes (1)

  • Efficacy (major liver resection)

    7 days

Study Arms (4)

Active treatment minor hepatic resection

EXPERIMENTAL

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

Drug: HRX215 capsules

Active treatment major hepatic resection

EXPERIMENTAL

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

Drug: HRX215 capsules

Major hepatic resection (Randomized part control arm)

PLACEBO COMPARATOR

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

Drug: Placebo capsules

Major hepatic resection (Randomized part)

EXPERIMENTAL

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

Drug: HRX215 capsules

Interventions

HRX215 capsulesDRUG

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

Active treatment major hepatic resectionActive treatment minor hepatic resectionMajor hepatic resection (Randomized part)
Placebo capsulesDRUG

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

Major hepatic resection (Randomized part control arm)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Liver Cirrhosis
  • Preoperative presence of clinical ascites
  • Any other hepatobiliary cancer
  • BMI \>35 kg/m2
  • ASA Score \>4
  • Peritoneal carcinomatosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Rabin Medical Center

Petah Tikva, Israel

NOT YET RECRUITING

Sheba Medical Center

Ramat Gan, Israel

NOT YET RECRUITING

Tel-Aviv Sourasky MC

Tel Aviv, Israel

NOT YET RECRUITING

Study Officials

  • Linda E Greenbaum, MD

    HepaRegeniX GmbH

    STUDY DIRECTOR

  • Patrick Starlinger, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wolfgang Albrecht, PhD NC

CONTACT

+49 7071 7912809info@heparegenix.com

Linda Greenbaum, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2024

First Posted

October 15, 2024

Study Start

May 6, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)IL(3)