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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath

In brief

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.

Key facts

Study ID

NCT05804045

Run by

Abbisko Therapeutics Co, Ltd

People needed

94

Starts

2023-04-27

Expected to finish

2028-06-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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