Tigilanol Tiglate in Participants with Head and Neck Solid Malignancies
Research type
Research Study
Full title
A Phase II, open label, single arm study to assess the efficacy of intratumoural tigilanol tiglate in various head and neck solid malignancies.
IRAS ID
1005472
Contact name
Peter Schmidt
Contact email
Sponsor organisation
QBiotics Group Limited
Clinicaltrials.gov Identifier
Research summary
This is an open label study looking at the efficacy of one or more intratumoural injections of investigation medicinal product (tigilanol tiglate) in participants with recurrent and/or metastatic head and neck cancers that have failed at least one line of systemic therapy. For a patient to be eligible for this study, they need to have disease amenable to intratumoural injection either by palpation or under ultrasound guided injection. For each participant, the maximum duration of the study will be approximately 19 months (i.e., from the start of Screening to the end of Follow-up), except in the case of early withdrawal or discontinuation. Participation in the study includes a 28-day screening period prior to first treatment, followed by first tigilanol tiglate treatment (Tx1). If additional treatments are required (up to 5 are allowed according to the study protocol), they will take place at least 28 days apart. Injections can be performed until full ablation or until the study doctor decides that is no longer clinically appropriate.
The primary objective of the trial is to evaluate tumour ablation following treatment(s) with intratumoural injections of tigilanol tiglate.
This study targets the enrolment of approximately 37 participants across sites in the UK and Australia. Multiple sites are expected to participate in the UK, with Professor Kevin Harrington, at the Royal Marsden NHS Foundation Trust, serving as National Coordinating Investigator.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0310
Date of REC Opinion
18 Nov 2022
REC opinion
Further Information Favourable Opinion