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NCT05804045

PHASE3

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

Sponsor: Abbisko Therapeutics Co, Ltd

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in patients with Tenosynovial Giant Cell Tumor (TGCT). The main questions it aims to answer are: * Whether the Pimicotinib(ABSK021) works well in patients with TGCT. * Whether the Pimicotinib(ABSK021) is safe in patients with TGCT. Participants will be asked to complete the study procedures: * Receive the administration of Pimicotinib(ABSK021) or placebo (a placebo is a look-alike substance that contains no active drug) about 24 weeks in study part 1. * Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2. * Receive the administration of Pimicotinib(ABSK021) till study end in study part 3. * Complete the study procedures speficied in the protocol, which is guided by researchers.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-04-27

Completion Date

2028-06

Last Updated

2025-09-08

Healthy Volunteers

Conditions

Tenosynovial Giant Cell Tumor Pigmented Villonodular Synovitis Giant Cell Tumor of Tendon Sheath

Interventions

DRUG

Pimicotinib(ABSK021)

capsule

DRUG

Placebo

capsule

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 inducers as outlined in study protocol. * Impaired cardiac function or clinically significant cardiac disease. * Known active human immunodeficiency virus, active hepatitis B, active hepatitis C, or known active tuberculosis. * Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study. * Pregnant or lactating women. * Childbearing potential males or non-surgically sterilized female patients must agree to use effective methods of contraception during the study. * Any other clinically significant comorbidities, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.

Locations (40)

Precision NextGen Oncology

Beverly Hills, California, United States

Duke University Medical Center

Durham, California, United States

Henry Ford Health System

Detroit, Michigan, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

McGill University Health Center

Montreal, Canada

Princess Margaret Cancer Center

Toronto, Canada

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Jinan University

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

Enshi, Hubei, China

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Drum Tower hospital

Nanjing, Jiangsu, China

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, China

Weifang People's Hospital

Weifang, Shandong, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Xi'an Honghui Hospital

Xi’an, Shanxi, China

West China Hospital Sichuan University

Chengdu, Wuhan, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Beijing Jishuitan Hospital

Beijing, China

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Ospedale di Prato

Prato, Italy

Leiden University Medical Center

Leiden, Netherlands

Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Fundacion Jimenez Diaz

Madrid, Spain

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (40)