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Chitin

The active substance used in the T-ChOS capsule formulation is a chitooligosaccharide blend.

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

T-ChOS

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.

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.

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)

Serum YKL-40 during and following 4 weeks of treatment with T-ChOS

Serum CRP during and following 4 weeks of treatment with T-ChOS

• time to reach maximum plasma concentration (tmax)

• area under the plasma concentration-time curve from zero to the last measurable time point (AUC0-t)

• area under the plasma concentration-time curve from zero to infinity (AUC)

• apparent plasma clearance following oral administration (CL/F)

Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.

ORR = complete response + partial response, according to RECIST 1.1

DCR = complete response + partial response + stable disease, according to RECIST 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)	NCT03320525	Advanced Solid ...	T-ChOS	18 Years - 75 Years	Herlev Hospital
Pharmacokinetic Profile of T-ChOS™ in Subjects With Advanced Solid Tumors (CHITIN)	NCT03320525	Advanced Solid ...	T-ChOS	18 Years - 75 Years	Herlev Hospital

Spots Global Cancer Trial Database for benecta

Every month we try and update this database with for benecta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for benecta

Every month we try and update this database with for benecta cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for benecta cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.