A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study of ABSK021 to Assess the Efficacy and Safety in Patients with Tenosynovial Giant Cell Tumor - ABSK021-301

Abbisko Therapeutics Co. Ltd.0 个研究点目标入组 95 人开始时间: 2023年5月5日最近更新: 2024年7月22日

适应症

试验速览

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•Patients should understand the study procedures and sign the informed consent form prior to screening, Age = 18 years, A histologically confirmed TGCT with not amenable to surgery prior to randomization., Measurable disease as defined by RECIST 1.1, and with at least one lesion of = 2 cm prior to randomization., Stable prescription of analgesic regimen for patients with an analgesic need during the 2 weeks prior to randomization., 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., Adequate organ function and bone marrow function.

•Known allergy or hypersensitivity to any components of the investigational drug product, Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R prior to randomization. However, patients who have received prior treatment with multi-kinase inhibitors that include the CSF-1/CSF-1R pathway are allowed, such as Imatinib and otinib, 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, Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization, or unhealed, infected, or dehiscence of previous surgical wounds, or adverse events from prior therapies did not recover to = Grade 1 (CTCAE 5.0)., Impaired cardiac function or clinically significant cardiac disease, Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study.

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