TANGENT
Research type
Research Study
Full title
A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy ofEmactuzumab vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour.
IRAS ID
1004382
Contact name
Axel Mescheder
Contact email
Sponsor organisation
SynOx Therapeutics Ltd
Eudract number
2021-001716-29
Clinicaltrials.gov Identifier
Research summary
The aim of this study is to assess the safety and efficacy of a new drug called emactuzumab and to compared it to a placebo (a dummy drug), in participants with tenosynovial giant cell tumour (TGCT). Potential participants will have TGCT and surgery to remove or reduce the tumour is not currently considered an appropriate option. Emactuzumab is a novel monoclonal antibody inhibiting the CSF-1 receptor. CSF-1 enzymes are linked to a process which can cause tumour growth in the body. Emactuzumab blocks this process by binding specifically to the CSF-1 receptors, potentially reducing the growth of these tumours. This study is a Phase III, Randomised, Double-Blind study. Two thirds of participants will receive study drug and one third will receive placebo. It also has an open-label component, in which all parties will know that they are receiving emactuzumab. The approximate total duration of study participation will be two years. Participants will be required to visit the hospital every second week during the initial treatment period for an IV infusion. Thereafter, the participants will partake in a follow-up period for up to 24 months from the first visit. Participants may be asked to take part in an open-label retreatment study. To assess the antitumour activity of emactuzumab, response to treatment will be determined from radiographic measurements. Participants will be monitored for toxicity and if necessary, the treatment plan will be modified individually, including temporary or permanent discontinuation of study treatment. The effect of emactuzumab on physical functioning, pain and quality of life will also be assessed. The following study procedures will be performed (a) ECGs, (b) physical examinations (c) blood tests, (d) urine tests (e) MRI scans (f) pain and mobility assessments (g) IV infusion of study drugs (h) questionnaires.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
22/NW/0160
Date of REC Opinion
19 Jul 2022
REC opinion
Further Information Favourable Opinion