Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

Launched by SYNOX THERAPEUTICS LIMITED · Jun 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called emactuzumab for patients with a condition known as Tenosynovial Giant Cell Tumor (TGCT). TGCT is a type of tumor that can cause pain and limit movement, and in some cases, surgery is not a good option for treatment. The trial is looking for participants who are 12 years or older and have been diagnosed with either localized or diffuse TGCT, where surgery could lead to more problems or isn't expected to help. To participate, patients should have measurable disease and adequate organ function, and women of childbearing age will need to have a negative pregnancy test and use effective contraception.

Participants in the trial will receive either emactuzumab or a placebo (a substance with no active medicine) through an intravenous infusion every two weeks for a total of five treatments over 24 weeks. During this time, doctors will closely monitor their health through various tests and assessments. After this initial phase, there will be an observation period, and patients who received the placebo may have the chance to receive emactuzumab later on. This trial is currently recruiting participants, and those interested should talk to their healthcare provider to see if they qualify.

Gender

ALL

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.
• • 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.