Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
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. * Whether the Pimicotinib(ABSK021) is safe in patients with TGCT. 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.
Timeline
- Start
- 2023-04-27
- Primary completion
- 2024-09-23
- Completion
- 2028-06
Outcome
Met primary endpoint
registry Part 1- Pimicotinib(ABSK021) vs Part 1- Placebo; p <0.0001; Risk Difference (RD) 50.7; Fisher Exact NCT05804045 ↗
paper ORR at week 25 was 54% (34 of 63) in the pimicotinib group and 3% (one of 31) in the placebo group PMID 41796601 ↗
release “Phase III MANEUVER trial of pimicotinib met its primary endpoint, demonstrating significant improvement in objective response rate in TGCT-patients.” emdgroup.com ↗
release “Global Phase 3 MANEUVER study of pimicotinib in tenosynovial giant cell tumor (TGCT) met the primary endpoint” emdgroup.com ↗
release “MANEUVER trial . In the trial, TGCT patients who received once-daily oral pimicotinib achieved a statistically significant improvement in the primary endpoint” abbisko.com ↗
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pimicotinib | Small molecule | 50 mg | Oral |