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New pill shows promise for rare joint tumor in Late-Stage trial

NCT ID NCT05804045

Disease control Sponsor: Abbisko Therapeutics Co, Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether the drug Pimicotinib (ABSK021) can shrink tumors and improve symptoms in people with tenosynovial giant cell tumor (TGCT), a rare, non-cancerous growth in joints that cannot be surgically removed. About 94 adults will receive either the drug or a placebo for 24 weeks, followed by open-label treatment. The main goal is to see how many patients respond with tumor shrinkage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pimicotinib (ABSK021)
What this could lead to
If it works, this could offer a new treatment option for people with TGCT that cannot be removed by surgery, potentially shrinking tumors and easing symptoms.
What could go wrong
This is a relatively small Phase 3 trial, and the drug may not prove more effective than placebo. Side effects are possible, and long-term benefits are not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

94 people

The number who actually took part.

Started

Apr 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Giant Cell Tumor of Tendon Sheath tenosynovial giant cell tumor tenosynovial giant cell tumor, diffuse type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Giant cell tumor of tendon sheath Pigmented villonodular synovitis Tenosynovial giant cell tumor

Contacts and locations

Locations

  • Beijing Jishuitan Hospital

    Beijing, China

  • Duke University Medical Center

    Durham, California, 27710, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hunan Provincial People's Hospital

    Changsha, Hunan, China

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna, Italy

  • Leiden University Medical Center

    Leiden, 2333, Netherlands

  • Liaoning Cancer Hospital&Institute

    Shenyang, Liaoning, China

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, Poland

  • McGill University Health Center

    Montreal, Canada

  • Nanjing Drum Tower hospital

    Nanjing, Jiangsu, China

  • Ospedale di Prato

    Prato, Italy

  • Peking University People's Hospital

    Beijing, Beijing Municipality, China

  • Precision NextGen Oncology

    Beverly Hills, California, 90212, United States

  • Princess Margaret Cancer Center

    Toronto, Canada

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263, United States

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, China

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, China

  • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

    Enshi, Hubei, China

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, China

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, China

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030, United States

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

    Wuhan, Hubei, China

  • Weifang People's Hospital

    Weifang, Shandong, China

  • West China Hospital Sichuan University

    Chengdu, Wuhan, China

  • Xi'an Honghui Hospital

    Xi’an, Shanxi, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.