Safety of HRX215 in Patients After Minor and Major Liver Resection

HepaRegeniX GmbH

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Colorectal Carcinoma Liver Metastases; Liver Resection

Treatments: Drug: Placebo capsules; Drug: HRX215 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, 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.

Full description

The study is designed to evaluate primarily the safety of HRX215, first after minor liver resection and subsequently in participants after major liver resection. Participants undergoing major liver resection will start treatment shortly before liver resection surgery and will receive 28 days of treatment with HRX215 or placebo twice daily with follow up visits at 3 and 6 months.

Participants will take HRX215 or a placebo twice a day for 28 days. Daily visits for the first 7 days of treatment 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. Additional clinic visits 3 months and 6 months after the start of treatment.

The pharmacokinetics will be compared with the results of the phase I studies in healthy subjects.

Secondary objectives will include evaluation of liver volume and liver volume increase postoperatively.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

Active treatment minor hepatic resection

Experimental group

Description:

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

Treatment:

Drug: HRX215 capsules

Active treatment major hepatic resection

Experimental group

Description:

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

Treatment:

Drug: HRX215 capsules

Major hepatic resection (Randomized part control arm)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo capsules

Major hepatic resection (Randomized part)

Experimental group

Description:

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

Treatment:

Drug: HRX215 capsules