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NCT05417789

PHASE3

Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

Sponsor: SynOx Therapeutics Limited

View on ClinicalTrials.gov

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.

Official title: A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects With Tenosynovial Giant Cell Tumour

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2024-10-09

Completion Date

2027-09-30

Last Updated

2026-02-02

Healthy Volunteers

Conditions

TGCT

Interventions

DRUG

Emactuzumab

Emactuzumab administered once every 2 weeks (q2w)

DRUG

Placebo

Matching placebo administered once every 2 weeks (q2w)

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.

Locations (48)

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

AP-HP - Hôpital Cochin - Port-Royal, site Cochin

Paris, Paris, France

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

Lyon, Rhône, France

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, 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 Universitario Fundacion Jimenez Diaz

Zaragoza, Zaragoza, 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 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