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Tenosynovial Giant Cell TumorPhase 3NCT05804045

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

A Phase 3 study testing Pimicotinib(ABSK021) in people with Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, run by Abbisko Therapeutics Co, Ltd at 40 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pimicotinib(ABSK021)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
94 participants
Where
40 sitesin 7 countries
Study dates
27 Apr 2023to Jun 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

40 sites in 7 countries.

40 sites in 7 countries

China23 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • Beijing Jishuitan Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China Hospital Sichuan University

    Chengdu, Wuhan

  • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

    Enshi, Hubei

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Nanjing Drum Tower hospital

    Nanjing, Jiangsu

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

  • Liaoning Cancer Hospital&Institute

    Shenyang, Liaoning

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

  • Weifang People's Hospital

    Weifang, Shandong

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

    Wuhan, Hubei

  • Xi'an Honghui Hospital

    Xi’an, Shanxi

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

United States8 sites

  • Precision NextGen Oncology

    Beverly Hills, California, 90212

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, California, 27710

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

    Houston, Texas, 77030

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

Other trials in United States

Italy3 sites

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

  • Ospedale di Prato

    Prato

Other trials in Italy

Canada2 sites

  • McGill University Health Center

    Montreal

  • Princess Margaret Cancer Center

    Toronto

Other trials in Canada

Spain2 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Fundacion Jimenez Diaz

    Madrid, 28040

Other trials in Spain

Netherlands1 site

  • Leiden University Medical Center

    Leiden, 2333

Other trials in Netherlands

Poland1 site

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw

Other trials in Poland

About this study

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

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.
Read more

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.
Read the detailed description

This study consists of part 1 and part 2. Part 1 is a double-blind phase, eligible patients will be randomized to Pimicotinib(ABSK021) treatment group or matching placebo group and will receive Pimicotinib(ABSK021) or matching placebo until completion of Part 1.

Part 2 is an open-label treatment phase, and all patients entering this phase will receive open-label Pimicotinib(ABSK021) until completion of 24 weeks of dosing or withdrawal from the study.

Part 3 is an open-label extension treatment phase, and patients who completed the part 2 and continuted to be eligible, will go to the Part 3. Patients will receive the open-label Pimicotinib(ABSK021) until all patients withdraw from the study, or the sponsor decides to terminate the study, whichever occurs first.

Being tested
Pimicotinib(ABSK021), Placebo
Medical subject headings
Giant Cell Tumor of Tendon Sheath, Synovitis, Pigmented Villonodular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pimicotinib(ABSK021)Drug

    capsule

  • PlaceboDrug

    capsule

Study groups in NCT05804045
Study groupRoleWhat they receive
Part 1/Part 2/Part 3- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)ExperimentalParticipants receive the blinded treatment of ABSK021 for 24 weeks in Part 1 and continue on the open-label Pimicotinib(ABSK021) in Part 2 and Part 3.
Receives: Drug: Pimicotinib(ABSK021)
Part 1- Placebo/ Pimicotinib(ABSK021)Placebo comparatorParticipants receive the blinded treatment of matching placebo for 24 weeks in Part 1 and have option to receive the open-label Pimicotinib(ABSK021) in Part 2.
Receives: Drug: Pimicotinib(ABSK021); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Assessed by central read using Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

    Measured: Baseline to Week 25

Secondary outcomes (5)

  1. Objective Response Rate (ORR) Per Tumor Volumn Score (TVS)

    TVS is a semi-quantitative magnetic resonance imaging (MRI) scoring system that describes tumor mass and is based on 10% increments of the estimated volume of the maximally distended synovial cavity or tendon sheath involved. A tumor that is equal in volume to that of a maximally distended synovial cavity or tendon sheath was scored 10; a score of 0 indicated no evidence of tumor. ORR was the percentage of participants who achieved either Complete Response (CR) or Partial Response (PR) as assessed by Blinded Independent Review Committee using TVS.

    Measured: Baseline to Week 25

  2. Change From Baseline in Active Range of Motion (ROM) at Week 25

    Presented here is the change from baseline in ROM to Week 25. Measurement of the affected and contralateral, non-affected joint was assessed by goniometer and measured in degrees. At baseline, the motion with the smallest relative ROM value (worst) was identified, and this motion was used for evaluating the change in relative ROM subsequently. The affected joint measurement was used to derive a relative ROM based on the measurement relative to reference standard value provided by the American Medical Association. Relative ROM is expressed in percent: 100 x (joint ROM measure)/(reference ROM standard).

    Measured: Baseline to Week 25

  3. Change From Baseline in the Worst Stiffness Numeric Rating Scale (NRS) Score at Week 25

    The Worst Stiffness NRS is a single question that asks the participant to assess their worst stiffness in the last 24 hours. Participants rate their worst stiffness on a scale of 0 to 10, where 0 is "no stiffness" and 10 is "worst imaginable." Lower scores represented better level of stiffness.

    Measured: Baseline to Week 25

  4. Change From Baseline in Brief Pain Inventory (BPI) Worst Pain NRS Score at Week 25

    Participants reported responses to the BPI Worst Pain NRS. The BPI Worst Pain NRS ranged from 0 to 10, where 0 is "no pain" and 10 is "pain as bad as you can imagine."

    Measured: Baseline to Week 25

  5. Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Score at Week 25

    All participants were asked 11 or 13 questions from the PROMIS-PF item bank. The questions used one of two 5-point verbal rating scales: either 1 = "unable to do", 2 = "with much difficulty", 3 = "with some difficulty", 4 = "with a little difficulty", and 5 = "without any difficulty"; or 1 = "cannot do", 2 = "quite a lot", 3 = "somewhat", 4 = "very little", and 5 = "not at all." The T-score rescales the total raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. The T-score ranges from 0 to 100, with a higher score indicating better physical function status.

    Measured: Baseline to Week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start27 Apr 2023
  3. Primary completion23 Sep 2024
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05804045
Sponsor's protocol ID
ABSK021-301
Status last verified
Apr 2026
First submitted
13 Mar 2023
Last updated
4 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gelderblom H, Niu X, Stacchiotti S, Stern S, Tinoco G. Pimicotinib versus placebo in tenosynovial giant cell tumor (TGCT): a plain language summary of the MANEUVER clinical trial. Future Oncol. 2026 Oct 14:1-12. doi: 10.1080/14796694.2026.2732810. Online ahead of print.

    PubMed 42872549

  • Xu H, Niu X, Ravi V, Martin-Broto J, Razak AA, Saleh R, Zhou Y, Shen J, Liu T, Sankhala KK, Serrano C, Stacchiotti S, Wang J, Baldi GG, Feng Y, Hua Y, Li T, Rutkowski P, Zhang X, Tinoco G, Zou Q, Shan B, Zhu X, Gelderblom H. Pimicotinib versus placebo for tenosynovial giant cell tumour (MANEUVER): an international, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 Mar 14;407(10533):1072-1083. doi: 10.1016/S0140-6736(25)02602-9. Epub 2026 Mar 5.

    PubMed 41796601

  • Niu X, Ravi V, Shan B, Guo Q, Shi H, Zou Q, Gelderblom H. MANEUVER: A Phase III study of pimicotinib to assess efficacy and safety in tenosynovial giant cell tumor patients. Future Oncol. 2026 Feb;22(5):507-514. doi: 10.1080/14796694.2024.2396227. Epub 2024 Sep 17.

    PubMed 39287124

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pimicotinib(ABSK021) in people with Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, run by Abbisko Therapeutics Co, Ltd at 40 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in China, United States, Italy, Canada, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Baseline to Week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05804045, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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