Status:
ACTIVE_NOT_RECRUITING
Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
Lead Sponsor:
SynOx Therapeutics Limited
Conditions:
TGCT
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05417789
Start Date
October 9 2024
End Date
September 30 2027
Last Update
December 23 2025
Active Locations (48)
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1
NextGen Oncology
Beverly Hills, California, United States, 90212
2
Sarcoma Oncology Research Center, LLC
Los Angeles, California, United States, 90067
3
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
4
University of Kansas Cancer Center (Overland Park) - USOR
Overland Park, Kansas, United States, 66210