NCT05608876

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: QBiotics Group Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Tigilanol Tiglate	Tigilanol tiglate is a novel, short-chain diterpene ester in clinical development for intratumoural treatment of a wide range of solid tumours.

Timeline

• Start date: 2022-11-03
• Primary completion: 2025-07-31
• Completion: 2026-08-01
• First posted: 2022-11-08
• Last updated: 2025-08-07

Locations

7 sites across 2 countries: Australia, United Kingdom