Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
NCT ID: NCT05417789
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
128 participants
INTERVENTIONAL
2024-10-09
2027-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1 in Part 1/Part 2: Emactuzumab
Group 1: Subjects receiving emactuzumab administered intravenously (i.v) on Day(D)1 and repeated once every two weeks (Q2W) for a total of 5 times, followed by an observation period of 3 months leading to a total period of 24 weeks in Part 1 and continued with a follow-up phase in Part 2. Eligible Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment in Part 2.
Emactuzumab
Emactuzumab administered once every 2 weeks (q2w)
Group 2 in Part 1 and Part 2: Placebo
Group 2: Subjects receiving placebo administered intravenously (i.v) on D1 and repeated once every two weeks (Q2W) for 5 times followed by an observation period of 3 months to a total period of 24 weeks in Part 1. In Part 2, Eligible Subjects will have the option to receive open-label emactuzumab, administered by i.v once every 2 weeks (Q2W) for a total of 5 times.
Placebo
Matching placebo administered once every 2 weeks (q2w)
Interventions
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Emactuzumab
Emactuzumab administered once every 2 weeks (q2w)
Placebo
Matching placebo administered once every 2 weeks (q2w)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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SynOx Therapeutics Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Jean Y Blay, Prof, MD
Role: PRINCIPAL_INVESTIGATOR
Comprehensive Cancer Centre of Lyon
Locations
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NextGen Oncology
Beverly Hills, California, United States
Sarcoma Oncology Research Center, LLC
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Kansas Cancer Center (Overland Park) - USOR
Overland Park, Kansas, United States
University of Minnesota
Minneapolis, Minnesota, United States
Duke Cancer Center
Durham, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
OHSU Knight Cancer Institute Hematology Oncology
Portland, Oregon, United States
MD Anderson Cancer Center
Houston, Texas, United States
MedStar Washington Hospital Center
Georgetown, Washington, United States
LKH-Universitätsklinikum Graz
Graz, , Austria
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium
UZ Gent - Department of Medical Oncology
Ghent, , Belgium
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Centre Antoine Lacassagne
Nice, Alpes-Maritimes, France
Institut Bergonie - PPDS
Bordeaux, Gironde, France
Institut de Cancerologie de Ouest - Saint Herblain
Saint-Herblain, Loire-Atlantique, France
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, Rhône, France
UNICANCER - Centre Oscar Lambret
Lille, , France
AP-HP - Hôpital Cochin - Port-Royal, site Cochin
Paris, , France
Institut Curie - Hôpital de Paris
Paris, , France
Oncopole Claudius Regaud Oncologie Médicale
Toulouse, , France
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Lazio, Italy
Fondazione del Piemonte per l'Oncologia (IRCCS)
Candiolo, Piedmont, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
Pisa, Tuscany, Italy
Nuovo Ospedale di Prato
Prato, Tuscany, Italy
IRCCS lstituto Ortopedico Rizzoli
Bologna, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello
Pisa, , Italy
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Seoul National University Hospital
Seoul, , South Korea
Hospital Clinico San Carlos
Madrid, Madrin, Spain
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
Hospital Universitario Fundacion Jimenez Diaz
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Skanes Universitetssjukhus Lund
Lund, Skåne County, Sweden
Universitäts Kinderspital Beider Basel (UKBB)
Basel, , Switzerland
Inselspital - Universitätsspital Bern
Bern, , Switzerland
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
St James's University Hospital
Leeds, , United Kingdom
University College Hospital
London, , United Kingdom
Churchill Hospital, Cancer Haematology Center
Oxford, , United Kingdom
Countries
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Other Identifiers
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SNX-301-020
Identifier Type: -
Identifier Source: org_study_id