Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)

NCT07499362 | Recruiting Phase 2 DMC

• 2 other identifiers: MS265601_0008jRCT2071250149
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

The primary purpose of this study is to assess the tolerability, pharmacokinetics, and efficacy of pimicotinib in Japanese participants with TGCT

Conditions

Tenosynovial Giant Cell Tumor

Keywords

Nodular TGCT; diffuse TGCT; giant cell tumor of tendon sheath; colony-stimulating factor 1 receptor (CSF-1R) inhibitor

Outcome Measures

Primary Outcomes (3)

• Safety Run-In Cohort: Number of Participants with Dose Limiting Toxicity (DLT)-like events

  Day 1 up to Day 28 of Cycle 1 (each cycle is of 28 days)

• Safety Run-In Cohort: Pharmacokinetic (PK) Plasma Concentration of Pimicotinib

  Pre-dose up to 24 hours post-dose on Cycle 1 Day 1 and Cycle 1 Day 15 (each cycle is of 28 days)

• Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee

  Time from first study treatment until progressive disease or death, assessed up to approximately 2 years

Secondary Outcomes (16)

• Objective Response (OR) According to Tumor Volume Score (TVS) as Assessed by Independent Review Committee (IRC)

  Time from first study treatment until progressive disease or death, assessed up to approximately 2 years

• Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by Investigator

  Time from first study treatment until progressive disease or death, assessed up to approximately 2 years

• Mean Change from Baseline in Range of Motion (ROM) at Week 25

  Baseline, Week 25

• Mean Change from Baseline in Worst-Stiffness-Numeric Rating Scale (NRS) Score at Week 25

  Baseline, Week 25

• Mean Change from Baseline in Brief Pain Inventory (BPI)- Worst-Stiffness-Numeric Rating Scale (NRS) Score at Week 25

  Baseline, Week 25

Study Arms (1)

Safety Run-In followed by Expansion Cohort: Pimicotinib

EXPERIMENTAL

Drug: Pimicotinib

Interventions

Pimicotinib DRUG

In the Safety Run-in Cohort, participants will receive 50 milligrams (mg) of pimicotinib once daily (QD), orally in 28-day cycles until disease progression (DP), death, discontinuation, or any other reason. The Safety Monitoring Committee (SMC) will monitor and assess tolerability of pimicotinib 50 mg QD during the safety run-in cohort. After making a recommendation about opening the Expansion Cohort based on the assessment in safety run-in cohort, participants will receive 50 mg of pimicotinib monotherapy QD, orally in 28-day cycles until disease progression (DP), death, discontinuation, or any other reason.

Safety Run-In followed by Expansion Cohort: Pimicotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Japanese participants with a diagnosis of TGCT that has been histologically confirmed at the local laboratory and is unresectable (that is \[i.e.\] it is located in a complex anatomical site, extensively invasive, and cannot be completely resected; or a surgical operation may cause dysfunction or serious complications). Symptomatic disease because of active TGCT, defined as a worst pain of greater than or equal to \[\>=\] 4 within 2 weeks prior to enrollment (based on scale of 0 to 10, with 10 representing "pain as bad as you can imagine"), and/or a worst stiffness of \>= 4 within 2 weeks prior to first dose of pimicotinib (based on a scale of 0 to 10, with 10 representing "stiffness as bad as you can imagine")
• Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to \[\<=\] 1
• Participants with adequate hepatic, renal hematologic functions

You may not qualify if:

• Known additional malignancy that required active treatment and may affect the participant's participation in the study or affect the outcome of the study as assessed by the Investigator. Exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinoma in situ
• Serious gastrointestinal bleeding within 3 months of first dose of pimicotinib or factors that significantly affected the absorption of oral drug, such as inability to take oral medication or significant nausea and vomiting, malabsorption, external bile duct drainage, massive small-bowel resection, etc.
• Impaired cardiac function or clinically significant cardiac disease, including any one of the following: New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure; prolongation of the rate corrected QT interval based on repeated demonstration of QT interval corrected using Fridericia's formula (QTcF) greater than (\>) 480 milliseconds (ms), or history of long QT interval corrected (QTc) syndrome; Left ventricular ejection fraction (LVEF) less than (\<) 50 percent (%) or below the lower limit of normal, whichever is higher
• Cerebrovascular accident/stroke (within 6 months of first dose of pimicotinib)

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead
• Merck KGaA, Darmstadt, Germany: collaborator

Study Sites (3)

National Cancer Center Hospital

Chūōku, Japan

RECRUITING

Kyushu University Hospital - 300173484

Fukuoka, Japan

RECRUITING

Nagoya University Hospital - 300176284

Nagoya, Japan

RECRUITING

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Giant Cell Tumor of Tendon Sheath

Condition Hierarchy (Ancestors)

Giant Cell Tumors; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Synovitis; Joint Diseases; Musculoskeletal Diseases; Tendinopathy; Muscular Diseases

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Central Study Contacts

Communication Center

CONTACT

+49 6151 72 5200; service@emdgroup.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 30, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): November 22, 2029
• Study Completion (Estimated): November 22, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: IPD from completed trials will be publicly available within 6 months after all of the following events: * Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions * Public results via primary manuscript or trial registry disclosure * Legal authority to share data * Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21
• Access Criteria: Qualified researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/.

Locations

JP (3)