Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Phase 3

Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

NCT05417789 · tracked via the Priya Life Science Italy tracker
Sponsor
SynOx Therapeutics Limited
Phase
Phase 3
Started
2024-10-09
Last updated
2026-07-29

Condition(s) studied

TGCT

Investigational drug(s) / intervention(s)

Emactuzumab →Placebo

Emactuzumab: Emactuzumab administered once every 2 weeks (q2w)

Placebo: Matching placebo administered once every 2 weeks (q2w)

Study summary

This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is not viewed as an option.

The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1 ratio to receive either emactuzumab or matching placebo in a double-blind fashion, that will be administered in total 5 times as an intravenous (i.v.) infusion once every 2 weeks. This will be followed by an observation period of 3 months leading to a total duration of 24 weeks in Part 1. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. Part 2 is a long-term double-blind follow-up phase of the subjects on emactuzumab or placebo. Subjects assigned to placebo in Part 1 have the option, subject to eligibility, to crossover to receive open-label emactuzumab in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances.

Eligibility

Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \>12 years * Biopsy-confirmed (standard of care diagnosis history) local or diffuse TGCT where surgical resection would be associated with predicted worsening functional limitations through surgical joint damage, and/or subject has an anticipated high risk of early recurrence as determined by a multidisciplinary tumour board or equivalent, or any other morbidity associated with the surgery, and/or surgical treatment is not expected to improve the clinical outcomes of the subject. * Measurable disease: longest diameter ≥20 mm. * Adequate organ and bone marrow function * If a woman of childbearing potential (WOCBP), must have a negative pregnancy test prior to starting treatment and agree to use a highly effective method of contraception * Participants must have given written consent Exclusion Criteria: * If a female, the subject is pregnant or breast feeding. * Medical conditions, including auto-immune, requiring systemic immunosuppression. Any systemic treatment for these conditions (eg, glucocorticoids) is not allowed within 4 weeks of Screening and during the study. * Known metastatic TGCT or other active cancer that requires concurrent or planned treatment * Received systemic therapy for TGCT (investigational or approved) targeting CSF-1 or CSF-1R or any multi-tyrosine kinase inhibitor (eg nilotinib and imatinib) within 3 months prior to screening * Any surgery, chemotherapy or radiotherapy within 3 months of screening * Unresolved clinically significant toxicity from a previous treatment or any history of serious liver toxicity. * Current or chronic history of liver disease. * Inadequate renal and liver function * Systemic antiretroviral therapy within 3 months of baseline * Within 6 months of baseline has experienced: clinically significant myocardial infarction, severe/unstable angina pectoris, congestive heart failure New York Heart Association (NYHA) Class III or IV, or pulmonary disease (NYHA Criteria 1994) including severe thromboembolic event; incompletely healed clinically significant wounds, including bone fractures; pathological fracture or significant hypercalcaemia.

Primary outcome measure(s)

  • Overall Response Rate (ORR) — Day 0 - Day 180 (6 months)
    Objective Response Rate (ORR = complete response \[CR\] + partial response \[PR\]) by 6 months from initiation of therapy according to RECIST v1.1 based on independent, blinded central review

Trial sites (33)

FacilityCityRegionStatus
NextGen Oncology Beverly Hills California
USC Norris Comprehensive Cancer Center Los Angeles California
The Ohio State University Columbus Ohio
MD Anderson Cancer Center Houston Texas
MedStar Washington Hospital Center Georgetown Washington
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Brussels Capital
Arthur J.E. Child Comprehensive Cancer Centre Calgary Alberta
Princess Margaret Cancer Centre Toronto Ontario
McGill University Health Centre (MUHC) Montreal Quebec
Institut Bergonie - PPDS Bordeaux Gironde
Institut de Cancerologie de Ouest - Saint Herblain Saint-Herblain Loire-Atlantique
AP-HP - Hôpital Cochin - Port-Royal, site Cochin Paris Paris
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes Lyon Rhône
UNICANCER - Centre Oscar Lambret Lille France
Institut Curie - Hôpital de Paris Paris France
Oncopole Claudius Regaud Oncologie Médicale Toulouse France
Fondazione Policlinico Universitario Campus Bio-Medico Rome Lazio
Istituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina Elena Rome Lazio
Fondazione del Piemonte per l'Oncologia (IRCCS) Candiolo Piedmont
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Sicily
IRCCS lstituto Ortopedico Rizzoli Bologna Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy
Leids Universitair Medisch Centrum Leiden Netherlands
Seoul National University Hospital Seoul South Korea
Hospital Universitario Fundacion Jimenez Diaz Zaragoza Zaragoza
Hospital de La Santa Creu i Sant Pau Barcelona Spain
Hospital Universitario Virgen del Rocio - PPDS Seville Spain
Hospital Universitari i Politecnic La Fe de Valencia Valencia Spain
Skanes Universitetssjukhus Lund Lund Skåne County
Universitäts Kinderspital Beider Basel (UKBB) Basel Switzerland
Taipei Veterans General Hospital Taipei Taiwan
St James's University Hospital Leeds United Kingdom
University College Hospital London United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05417789 on ClinicalTrials.gov ↗ ← All trials in Italy