Double-Blind, Randomized, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of HRX215 in Participants After Major Hepatectomy, Preceded by Two Open Pilot Parts in Participants After Minor and After Major Hepatectomy Due to Colon Carcinoma Metastases

Study Identifier:
HRX215-CR03-LR01
CT.gov Identifier:
NCT06638502
EudraCT Identifier:
202552363059
EU Trial (CTIS) Number:
2025-523630-59-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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. 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bowel (Colorectal)
Metastatic Cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18 - 75 Years
Study Drug
Drug: Experimental: Active treatment minor hepatic resection
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

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

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Riccardo Caruso
Status
Recruiting
Condition(s) Treated at Site
Bowel (Colorectal)
Metastatic Cancer