Study to assess how safe and effective is HRX215 in participants who underwent minor and major liver surgery due to colon carcinoma metastases

Overview

Sponsor-declared trial summary

Key facts

Sponsor

HepaRegeniX GmbH

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-04-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

HepaRegeniX GmbH

External identifiers

EU CT number

2025-523630-59-00

ClinicalTrials.gov

NCT06638502

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy

- To assess the safety and tolerability of oral HRX215 in participants who had minor or major liver surgery due to CRLM
- To study how HRX215 is absorbed, modified, broken down, and removed from the body and compare these results between participants in this study and healthy individuals from earlier studies

Secondary objectives 1

1. To assess if HRX215 helps liver grow back after syrgery

Conditions and MedDRA coding

colon carcinoma metastases

Regulatory references

Scientific advice from competent authorities

Federal Institute For Drugs And Medical Devices, Swedish Medical Products Agency

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Participants aged 18 to 75 years (inclusive)
2. Participants with liver metastases originating from a colon carcinoma planned for R0-intended hepatectomy for colorectal liver metastases. a. For pilot part 1 only: stable within 1-3 days after minor liver resection, otherwise normal nontumor liver parenchyma proven by histopathology assessment of a liver biopsy within 3 months before surgery
3. Participants with remnant liver volume (RLV) or estimated future liver remnant (FLR) after resection: a. For participants in pilot Part 1, after minor liver resection (RLV > 69%) by preoperative magnetic resonance imaging (MRI).b. For participants in pilot Part 2 and main study Part 3: participants with an estimated FLR of 30% - 50% (inclusive) prior to resection, calculated from preoperative CT or MRI after subtraction of tumor volume.
4. Preoperative assessment indicating that the participant is at low risk for PHLF (estimated <3–5%) based on surgeon’s standard practice and consistent with E-AHPBA-ESSO-ESSR Innsbruck Consensus guidelines for preoperative liver function assessment before hepatectomy
5. General health status World Health Organization (WHO) 0 or 1 or ECOG status 0 or 1
6. Estimated life expectancy > 6 months
7. Patients whose preoperative biological parameters are: a. Platelets ≥ 100,000/mm3, b. Polynuclear neutrophils ≥ 1000/mm3 c. Hemoglobin ≥ 9 g/dL (Posttransfusion patients can be included) d. Creatinine < 1.5 × upper limit of normal (ULN) e. Bilirubin ≤ ULN f. Albumin > LLN g. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ ULN h. INR ≤ 1.5
8. Must agree to use highly effective contraception specified in the Appendix A of the protocol from the time of informed consent until at least 36 days (5 half-lives + 30 days) after the last dose of study drug.
9. Participants must have adequate non-tumor liver tissue available for baseline histology for safety assessment purposes, either from planned resection or archival tissue collection within 3 months
10. Written signed informed consent

Exclusion criteria 23

1. Liver cirrhosis
2. Preoperative presence of clinical ascites
3. Any other hepatobiliary cancer
4. Body mass index > 35 kg/m2
5. American Society of Anesthesiologists (ASA) Score ≥ 4
6. Peritoneal disease or findings indicating unresectability •Part 1: A Completeness of Cytoreduction (CC) Score greater than 0 identified: preoperatively or intraoperatively. Any preoperative or intraoperative findings indicating that curative resection is not achievable •Part 2 and main study part 3; Any preoperative radiologic finding consistent with peritoneal carcinomatosis. Any preoperative finding indicating that curative resection is not achievable
7. Ongoing participation or participation within the 28 days prior to inclusion in the study in another therapeutic trial with an experimental drug and during 6 month follow-up period post-hepatectomy.
8. Serious non-stabilized disease, active uncontrolled infection, or other serious underlying disorder likely to prevent the patient from receiving the treatment
9. Pregnancy (βHCG positive), breastfeeding
10. Contraindication to iodine contrast agents
11. Current treatment with anticoagulants (including DOACs, heparin,antivitamin K) that cannot be safety interrupted for at least 48 hrs before study treatment (Part 2 and 3).
12. Chemotherapy within the last 30 days preoperatively
13. More than 12 cycles or more than 6 months of preoperative chemotherapy
14. Anticipated need to start adjuvant chemotherapy prior to completion of 28 day treatment period including chemotherapy via intrahepatic arterial pump
15. Positive test at screening for active hepatitis B virus (HBV)/hepatitis C virus (HCV) or autoimmune hepatitis
16. Incomplete liver metastasis resection (recognized at time of surgery) (part 1).
17. Portal vein and/or hepatic vein embolization procedure (pilot part 2 and main study part) or surgical hepatic augmentation procedure e.g. ALPPS
18. Presence of high-grade dysplastic lesions which cannot be completely resected at the time of liver resection or a history of malignancy within the past five years prior to screening, except for subjects with completely resected basal cell carcinoma of the skin or carcinoma in situ of the cervix
19. Legal incapacity (persons in custody or under guardianship)
20. Deprived of liberty Subject (by judicial or administrative decision)
21. Impossibility to sign the informed consent document or to adhere to the medical follow-up of the trial for geographical, social or psychological reasons
22. Contraindications against MRI or CT exams (according to local medical practice)
23. Inability to discontinue a concomitant medication which is primarily cleared by CYP2D6 from initiation of study treatment through day 28.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Incidence, severity, and relatedness of AEs/SAEs
2. Changes from baseline in vital signs and physical examination findings
3. Changes from baseline in clinical laboratory parameters (hematology,blood, glucose) at prespecified time points
4. Plasma PK of HRX215 (Cmax, Tmax, AUC etc.); comparison with Phase 1 healthy-subject PK data

Secondary endpoints 1

1. Establishment of Efficacy (main study part 3): • Liver volume on POD1 and POD7 and increase in liver volume at POD7 vs. POD1 (absolute change from POD1 CT)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

HepaRegeniX GmbH

Sponsor organisation

HepaRegeniX GmbH

Address

Eisenbahnstrasse 63, Suedstadt Suedstadt

City

Tuebingen

Postcode

72072

Country

Germany

Scientific contact point

Organisation

HepaRegeniX GmbH

Contact name

Chief Medical Officer

Public contact point

Organisation

HepaRegeniX GmbH

Contact name

CEO

Third parties 11

Locations

3 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications