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Pimicotinib

Phase 2

Tenosynovial Giant Cell Tumor | Small molecule | Oncology |Merck KGaA|Last Updated: Sep 10, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Pimicotinib · 1 trial · 1 indication

Phase 2 1
NCT07499362Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)Tenosynovial Giant Cell Tumor
RECRUITING20 Analytics
PHASE2RECRUITING
Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)
Tenosynovial Giant Cell Tumor
NCT0749936220
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Safety Run-In followed by Expansion Cohort: PimicotinibEXPERIMENTAL -

Interventions

NameTypeDescription
PimicotinibDRUGIn 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * 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 ...

Countries:Japan
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Recent Changes (Last 90 Days)

LOWSep 10, 2026NCT07499362lastUpdatePostDate: changed
LOWSep 10, 2026NCT07499362lastUpdatePostDate: changed
LOWAug 11, 2026NCT07499362lastUpdatePostDate: changed
LOWAug 11, 2026NCT07499362lastUpdatePostDate: changed
LOWAug 11, 2026NCT07499362lastUpdatePostDate: changed
LOWJul 10, 2026NCT07499362lastUpdatePostDate: changed
LOWJul 10, 2026NCT07499362lastUpdatePostDate: changed