Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT) (TANGENT)
TGCT
About this trial
This is an interventional treatment trial for TGCT focused on measuring TGCT, Tenosynovial Giant Cell Tumour, PVNS, Pigmented Villonodular Synovitis, Synovitis, Emactuzumab, Local TGCT, Diffuse TGCT
Eligibility Criteria
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.
- 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 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 therapy for TGCT within 4 weeks prior to screening and 3 months prior to screening for pexidartinib
- 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)
Sites / Locations
- Medstar Washington Hospital Center
- Medstart Heart and Vascular Institute
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group 1 in Part 1/Part 2: Emactuzumab
Group 2 in Part 1 and Part 2: Placebo
Group 1: Subjects receiving emactuzumab administered 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.
Group 2: Subjects receiving placebo administered as iv infusion 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 will have the option to crossover under certain circumstances to open-label emactuzumab once every 2 weeks (Q2W) for a total of 5 times in Part 2.