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A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
A Phase II, Open Label, Single Arm Study To Assess The Efficacy Of Intratumoral Tigilanol Tiglate In Various Head And Neck Solid Malignancies

Clinical Trial Summary

A Phase II, open label, single arm study to assess the efficacy of intratumoural tigilanol tiglate in various head and neck solid malignancies.

Clinical Trial Description

Primary Objective 1. To evaluate tumour ablation following treatment(s) with intratumoural injections of tigilanol tiglate. Secondary Objectives 1. To assess the safety and tolerability of intratumoural injections with tigilanol tiglate. 2. To evaluate disease control by assessing time to local disease recurrence from last treatment. 3. To evaluate the tumour recurrence rate at injected tumour sites. 4. To evaluate survival by assessing Progression Free Survival (PFS). Exploratory Objectives 1. To assess the impact on Quality of Life (QoL). 2. To assess the degree of wound healing after each treatment. 3. To assess the tumour response in injected and non-injected tumours, based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. 4. To assess the tumour response according to intratumoural Response Evaluation Criteria in Solid Tumours (itRECIST). 5. To assess changes in tumour biomarkers. 6. To assess the tumour microenvironment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05608876
Study type Interventional
Source QBiotics Group Limited
Contact Head of Human Clinical Operations
Phone +61 (0) 738 708 933
Email enquiries@qbiotics.com
Status Recruiting
Phase Phase 2
Start date November 3, 2022
Completion date October 2026
View Details
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