Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)

Inclusion Criteria: * Patients should understand the study procedures and sign the informed consent form prior to screening. * Age ≥ 18 years. * A histologically confirmed TGCT with unresectable. * Measurable disease as defined by RECIST 1.1, and with at least one lesion of ≥ 2 cm. * Stable prescription of analgesic regimen for patients with an analgesic need. * Participants should complete stiffness and pain scales during the screening period, and symptomatic disease because of active TGCT should meet minimum requirements as outlined in study protocol. * ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1. * Adequate organ function and bone marrow function. Exclusion Criteria: * Known allergy or hypersensitivity to any components of the investigational drug product. * Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R. Previous therapy with imatinib and nilotinib is allowed. * Known additional malignancy that required active treatment and may affect the patient's participation in the study or affect the outcome of the study as assessed by the Investigator. * Known metastatic TGCT. * Significant concomitant arthropathy in the affected joint, serious disease, uncontrolled infection. * Known MRI contraindications. * Has factors that significantly affected the absorption of oral drug. * Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization. * Concomitant use of strong CYP inhibitors or inducer…