Safety of HRX215 in Patients After Minor and Major Liver Resection

HepaRegeniX GmbH

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Colorectal Liver Metastases; Liver Resection

Treatments: Drug: HRX215 capsules; Drug: Placebo capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT06638502

HRX215-CR03-LR01

Details and patient eligibility

About

The goal of this clinical trial is to learn if HRX215 is safe and tolerable in adults who have undergone surgical removal of metastatic tumor(s) due to colorectal carcinoma in the liver.

The main question it aims to answer are:

1. to learn about the safety of HRX215
2. to learn about how the body absorbs, distributes, and gets rid of HRX215 . Researchers will compare HRX215 to a placebo (a look-alike substance that contains no drug) to see what medical problems participants have when taking HRX215.

Participants will:

Take HRX215 or a placebo twice a day for 28 days Daily visits for 7 days for checkups and tests which may either be in the hospital or outpatient after 3 days. Clinic visits every two weeks for the next two visits. The visit at two weeks may be a home visit or clinic visit. Additional clinic visits 3 months and 6 months after the start of treatment

Full description

The study is designed to evaluate primarily the safety of HRX215, first after minor liver resection and, when safety is established, in those patients after major liver resection. Participants will start treatment within 1-3 days after liver resection and will receive 28 day treatment with HRX215 twice daily or placebo with follow up visits 3 and 6 months after completion of treatment.

The pharmacokinetics will be compared with the results of the phase I studies, whereas efficacy will be evaluated only descriptively. Secondary objectives will include evaluation of differences in liver volume recovery postoperatively and clinical outcomes including days in the ICU and 90 day mortality in participants who receive treatment with HRX215 vs. placebo.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Stable male and female patients between 18 and 75 years within 1-3 days after extended resection of the right or left liver lobe due to metastases of a colon carcinoma, but otherwise normal liver parenchyma proven by histopathology assessment of a liver biopsy within 3 months before surgery and liver functional parameters.

2. For the pilot phase less extended resections (remnant liver volume >69%) are required)

3. Percentage of Remnant Liver Volume (RLV) 28%-50% (randomized part of the study)

Exclusion criteria

1. Liver Cirrhosis
2. Preoperative presence of clinical ascites
3. Any other liver cancer
4. BMI >35 kg/m2
5. ASA Score>4
6. CC Score >0: all patients with pre-operatively or intra-operatively diagnosed peritoneal carcinosis or other pre-op or intra-op findings which would deem the patient to be unresectable, are excluded.
7. Incomplete liver metastasis resection -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 3 patient groups, including a placebo group

Active treatment minor hepatic resection

Experimental group

Description:

5 participants will receive HRX215 250 mg twice daily orally within 1-3 days after minor (\<=31%) liver resection for colorectal liver metastases for 28 days.

Treatment:

Drug: HRX215 capsules

Active treatment arm major hepatic resection

Active Comparator group

Description:

10 participants will receive HRX215 250 mg twice daily orally within 1-3 days after major (50-72%) liver resection for colorectal liver metastases for 28 days.

Treatment:

Drug: HRX215 capsules

placebo arm major hepatic resection

Placebo Comparator group

Description:

10 participants will receive placebo capsules with matching appearance to HRX215 twice daily orally within 1-3 days after major (50-72%) liver resection for colorectal liver metastases for 28 days

Treatment:

Drug: Placebo capsules