Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05804045 · ClinicalTrials.gov registry record · Phase 3
Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)
A Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Abbisko Therapeutics Co.
- Active
- Registry status
- Phase 3
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT05804045: Active Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, sponsored by Abbisko Therapeutics Co.
NCT05804045 is a Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis that is active but no longer recruiting, run by Abbisko Therapeutics Co. The registered enrollment target is 90 participants, below the 107-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05804045, a Phase 3 study of Tenosynovial Giant Cell Tumor and Pigmented Villonodular Synovitis, is active but no longer recruiting, sponsored by Abbisko Therapeutics Co.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Assessed by central read using Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pimicotinib(ABSK021)
Study Locations (20)
Guangdong
- Guangdong Provincial People's Hospital - Guangzhou
- The First Affiliated Hospital of Jinan University - Guangzhou
- The First Affiliated Hospital, Sun Yat-sen University - Guangzhou
California
- Precision NextGen Oncology - Beverly Hills
- Duke University Medical Center - Durham
Ohio
- The Cleveland Clinic Foundation - Cleveland
- The Ohio State University - Columbus
Other
- McGill University Health Center - Montreal
- Princess Margaret Cancer Center - Toronto
Hubei
- The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture - Enshi
- Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology - Wuhan
Michigan
- Henry Ford Health System - Detroit
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
Texas
- The University of Texas M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-04-27 |
| Est. Completion | 2028-06 |
| Phase | Phase 3 |
What the registry record for NCT05804045 still lists
NCT05804045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 107-participant average among 8 other Tenosynovial Giant Cell Tumor trials with a reported enrollment target (16% lower).
The record links to 3 conditions, with Tenosynovial Giant Cell Tumor appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05804045 names 20 study sites across 14 states, led by Guangdong, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05804045 about?
NCT05804045 is a clinical study titled "Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)". 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 s...
What is the current status of trial NCT05804045?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 90 participants. The study started on 2023-04-27. Estimated completion is 2028-06.
What conditions does trial NCT05804045 study?
This clinical trial studies the following conditions: Tenosynovial Giant Cell Tumor, Pigmented Villonodular Synovitis, Giant Cell Tumor of Tendon Sheath.
What interventions are being tested in trial NCT05804045?
The interventions under investigation include: Placebo (DRUG), Pimicotinib(ABSK021) (DRUG).
Who is sponsoring clinical trial NCT05804045?
This trial is sponsored by Abbisko Therapeutics Co, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05804045 being conducted?
This trial has 20 study locations across California, Michigan, New York, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tenosynovial Giant Cell Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05804045's enrollment target sits among peer trials
90 6th of 8 higher than 3 of 8 other Tenosynovial Giant Cell Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tenosynovial Giant Cell Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Vimseltinib for Tenosynovial Giant Cell Tumor
ACTIVE NOT RECRUITING · Phase 3
-
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
COMPLETED · Phase 3
-
Tenosynovial Giant Cell Tumor (TGCT) Real-World Participant Experience With Vimseltinib
RECRUITING
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor
RECRUITING · Phase 1
-
A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment
RECRUITING
-
Study of Vimseltinib (DCC-3014) in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor
ACTIVE NOT RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02521311 · 90 participants · Phase 2
Assessment of Clemastine Fumarate as a Remyelinating Agent in Acute Optic Neuritis (ReCOVER)
- NCT02939573 · 90 participants · Phase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
- NCT03128879 · 90 participants · Phase 2
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
- NCT03184038 · 90 participants · NA
Neurocognition in Patients With Multiple Brain Metastases Treated With Radiosurgery
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI