Safety of HRX215 in Patients After Minor and Major Liver Resection

Conditions

• Colorectal Carcinoma Liver Metastases
• Liver Resection

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• HRX215 capsules — DRUG
  HRX215 250 mg orally twice daily for a total treatment duration of 28 days
• Placebo capsules — DRUG
  placebo matching appearance of HRX215, orally twice daily for a total treatment duration of 28 days

Study Details

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.

Key Dates

Start date

May 6, 2025

Status verified

May 2026

Primary completion

Jul 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

80 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

Adverse Events (AEs) observed [ Time Frame: 6 months ]

Central Contacts

• Wolfgang Albrecht, PhD NC
  +49 7071 7912809
  [email protected]
• Linda Greenbaum, MD
  484-343-2409
  [email protected]

Locations (1)

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