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