NCT03320525

Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

A Single Center, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single center phase 1 trial, which evaluates the pharmacokinetic profile of T-ChOS™ (food supplement Benecta™) in subjects with advanced solid tumors.

Detailed description

YKL-40 (also named chitinase 3 like-1 protein, CHI3L1), is a member of the mammalian chitinase like proteins and is a highly conserved glycoprotein. YKL-40 is produced by cancer cells and macrophages and promotes cancer progression by activating inflammation and inhibiting tumor angiogenesis. Thus, YKL-40 could be a new therapeutic target for patients with cancer. T-ChOS™ is a technical name for a food supplement product that is marketed in Iceland under the name Benecta™. T-ChOS is manufactured using shellfish derived chitin as a raw material and is produced by Genis in Iceland. It is a blend of chitooligosaccharides that are hetero-complexes of N-acetyl-glucosamine and D-glucosamine. T-ChOS chitooligosaccharides have been specially selected to have high bioactivity in inflammatory models and strong binding affinity to YKL-40. Chitooligosaccharide induced blockade of YKL-40 signalling pathways may represents a promising approach. Pharmacokinetic profile of the T-ChOS in patients with advanced solid malignancies is not available. Safety and tolerability data will be collected to expand the safety/tolerability database for patients with advanced solid malignancies treated with oral T-ChOS. Patients will be allowed to receive T-ChOS on a continuous basis and therefore have the possibility to gain clinical benefit, if any. Safety and tolerability data collected after pharmacokinetic part of the study will be also added to the safety database for patients with advanced solid malignancies treated with oral T-ChOS.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	T-ChOS	T-ChOS 600 mg (two capsules, each 300 mg) daily in the morning 30 minutes before food.

Timeline

• Start date: 2017-11-29
• Primary completion: 2018-09-25
• Completion: 2018-09-25
• First posted: 2017-10-25
• Last updated: 2018-10-02

Locations

1 site across 1 country: Denmark