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Pimicotinib · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Safety Run-In followed by Expansion Cohort: Pimicotinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
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 ...
Pimicotinib is being studied for the treatment of tenosynovial giant cell tumor (TGCT), a rare tumor that affects the joints and tendon sheaths. It is an investigational therapy in Phase 2 clinical development and has not been approved for any indication.
Pimicotinib is a small molecule kinase inhibitor, belonging to the -tinib class of drugs. Kinase inhibitors work by blocking specific enzymes that drive cell signaling. By targeting kinase activity, pimicotinib is designed to interfere with the signaling pathways that contribute to tumor growth in tenosynovial giant cell tumor.
Pimicotinib is being developed by Merck KGaA, which trades under the ticker MKGAF. The company is advancing the drug as an investigational treatment for tenosynovial giant cell tumor, a rare oncology indication.
Pimicotinib is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 study is evaluating the drug in patients with tenosynovial giant cell tumor.
Pimicotinib is being evaluated in one active clinical trial: NCT07499362, titled "Study of Pimicotinib in Japanese Participants With Tenosynovial Giant Cell Tumor (TGCT) (J-MANEUVER)." This Phase 2 trial is currently recruiting and plans to enroll 20 participants in Japan.