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
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Minnesota
Mayo Clinic
RECRUITING
Rochester
Other Locations
France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
NOT_YET_RECRUITING
Lille
Israel
Rabin Medical Center
NOT_YET_RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Tel-Aviv Sourasky MC
NOT_YET_RECRUITING
Tel Aviv
Spain
South Texas Accelerated Research Therapeutics Madrid - CIOCC - Universitario Sanchinarro
NOT_YET_RECRUITING
Madrid
Contact Information
Primary
Wolfgang Albrecht, PhD NC
info@heparegenix.com
+49 7071 7912809
Backup
Linda Greenbaum, MD
l.greenbaum@heparegenix.com
484-343-2409
Time Frame
Start Date:2025-05-06
Estimated Completion Date:2027-12-31
Participants
Target number of participants:80
Treatments
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.