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

Phase 1

Terminated

• Conditions: Advanced Solid Tumors
• Interventions: Dietary Supplement: T-ChOS

• Registration Number: NCT03320525
• Lead Sponsor: Herlev Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2017-10-14
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-25
• Study Start: 2017-11-29
• Status Verified: 2018-09
• Primary Completion: 2018-09-25
• Study Completion: 2018-09-25
• Last Update Submitted: 2018-09-30
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters will be assessed for T-ChOS	Approximately up to 12 months	• terminal half-life (t½)

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	Approximately up to 18 months.	ORR = complete response + partial response, according to RECIST 1.1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Approximately up to 18 months.	Safety and tolerability of the treatment regimens assessed by a summary of adverse events and clinical laboratory assessments.
Disease control rate (DCR)	Approximately up to 18 months.	DCR = complete response + partial response + stable disease, according to RECIST 1.1

Trial Locations

Locations (1)

Herlev & Gentofte University Hospital, Denmark; 🇩🇰 Herlev, Denmark