eligibility_summary
Eligible: ≥12, biopsy-confirmed TGCT where surgery likely harmful/high recurrence/no benefit, lesion ≥20 mm, adequate organ/marrow function, WOCBP negative test + contraception, consent. Exclude: pregnant/breastfeeding, systemic immunosuppression, metastatic TGCT/active cancer, ≤3 mo CSF1/CSF1R/MKI therapy or surgery/chemo/RT, liver disease/toxicity, renal/hepatic dysfunction or unresolved toxicity, antiretrovirals, ≤6 mo cardiopulmonary, TE, unhealed wounds/fractures, hypercalcemia.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Emactuzumab (RG7155), a humanized IgG1 monoclonal antibody immunotherapy targeting CSF1R, versus placebo. Dosing: IV every 2 weeks ×5 (Phase 3, randomized, double-blind). Mechanism of action: Emactuzumab binds and blocks CSF1R, inhibiting CSF1/M-CSF signaling and depleting CSF1R+ macrophages via receptor blockade and Fc-mediated clearance, reducing the macrophage-driven tumor burden typical of TGCT. Target cells/pathways: CSF1–CSF1R axis on synovial macrophages and osteoclast-like giant cells (tumor-associated macrophages/giant cells) within the joint, downstream macrophage survival/proliferation signaling pathways activated by CSF1R (e.g., PI3K/AKT and MAPK/ERK). Placebo is an inert comparator.