Active not recruitingPHASE3INTERVENTIONAL

Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)

This research study, called MANEUVER, is looking at a new drug named Pimicotinib (also known as ABSK021) for people with Tenosynovial Giant Cell Tumour (TGCT). This is a rare condition that affects the joints, sometimes causing pain and swelling. The study wants to find out if Pimicotinib can effectively treat TGCT and if it's safe to use. Participants will receive either the study drug or a look-alike inactive substance (placebo) for certain periods, followed by receiving only the study drug. The study is divided into three parts and will help doctors understand more about treating TGCT.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Abbisko Therapeutics Co, Ltd

Enrolment target

Start

27 Apr 2023

Estimated completion

01 Jun 2028

Tenosynovial Giant Cell Tumor Pigmented Villonodular Synovitis Giant Cell Tumor of Tendon Sheath

Results

Results from this study

Posted May 2026

Results have been published for this study.

Primary outcome

Objective Response Rate (ORR)

Assessed by central read using Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Full results on the registry

What is this study about?

This study is called MANEUVER and it's investigating a new medication, Pimicotinib (you might also see it called ABSK021), for a condition called Tenosynovial Giant Cell Tumor (TGCT). TGCT is a rare type of growth that can appear in joints like the knee, hip, or shoulder. It’s not cancer, but it can cause pain, swelling, and limit movement. Sometimes, these growths can't be fully removed with surgery, and that's where this study comes in. The main purpose is to see if Pimicotinib can help shrink these growths and improve symptoms for people who have TGCT that can’t be easily removed.

The researchers are particularly interested in two main points: first, how well Pimicotinib works in treating TGCT, and second, how safe it is for people to take. To do this, some participants will receive the active study drug, while others will get a placebo – which looks exactly like the real drug but contains no active medicine. This allows the researchers to fairly compare the effects of the new drug.

This study is a Phase 3 trial, which means it’s one of the final steps in testing a new medicine before it might become widely available. It's designed to gather a lot of information to help doctors understand the benefits and risks of Pimicotinib for people with TGCT.

Key takeaways

This study tests a new drug, Pimicotinib, for non-surgical Tenosynovial Giant Cell Tumor (TGCT).
It aims to find out if the drug works and is safe.
Participation involves receiving either Pimicotinib or a placebo initially, then only Pimicotinib.
Regular health checks and tests will be part of the study.
You must be over 18 with confirmed TGCT that cannot be removed by surgery.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of Tenosynovial Giant Cell Tumor (TGCT) that doctors can’t fully remove with surgery. The tumour also needs to be a certain size and visible on scans.

You should be feeling well enough to participate in daily activities, and if you take pain medication for your TGCT, your dose should be stable. Also, importantly, you must understand what the study involves and agree to take part by signing a consent form.

There are also some reasons why you might not be able to join. For example, if you've had a strong allergic reaction to similar medicines before, or if you have certain other serious health conditions like heart problems, uncontrolled infections, or severe liver disease. Pregnant or breastfeeding women also can't take part. The research team will carefully check all these details with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Tenosynovial Giant Cell Tumour (TGCT) that doctors say can't be easily removed by surgery?
Are you generally well enough for daily activities?
Are you willing and able to attend regular appointments and follow study instructions?
Are you free from serious heart, kidney, or liver conditions, or active infections?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it will be split into three parts. In the first part, which lasts about 24 weeks, you will either receive Pimicotinib or a placebo (a dummy pill). You won’t know which one you’re taking, and neither will your local doctor or the study team – this is called a “double-blind” phase. You'll have regular visits for check-ups and tests.

After 24 weeks, you’ll move into Part 2, where everyone will receive Pimicotinib for another 24 weeks. This phase is “open-label,” meaning you and the study team will know you are receiving the active drug. If you complete Part 2 and are still eligible, you could then move to Part 3. In Part 3, you'll continue to receive Pimicotinib until the study ends, or you or the study sponsor decide to stop your involvement.

Throughout the study, you’ll have regular appointments where the study team will see how you’re doing, ask about your symptoms (like pain and stiffness), and conduct various tests, such as blood tests and scans, to monitor your health and how the treatment is working. It’s important to attend all scheduled appointments and follow the study instructions carefully.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as access to a new treatment that might help your Tenosynovial Giant Cell Tumor before it’s widely available. You'll also receive close medical attention and monitoring throughout the study. However, there are potential risks, as Pimicotinib is a new drug, and not all its side effects are fully known. You might experience side effects from the medication, or it might not work for you. There's also a chance you could receive the placebo for the first 24 weeks. Your safety and well-being are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (40)

Precision NextGen Oncology
Verified postcode
Beverly Hills, United States
Duke University Medical Center
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Durham, United States
Henry Ford Health System
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Detroit, United States
Roswell Park Comprehensive Cancer Center
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Buffalo, United States
The Cleveland Clinic Foundation
Verified postcode
Cleveland, United States
The Ohio State University
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Columbus, United States
The University of Texas M.D. Anderson Cancer Center
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Houston, United States
Fred Hutchinson Cancer Center
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Seattle, United States
McGill University Health Center
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Montreal, Canada
Princess Margaret Cancer Center
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Toronto, Canada
The First Affiliated Hospital of Bengbu Medical College
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Bengbu, China
Peking University People's Hospital
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Beijing, China

Common questions

What is Tenosynovial Giant Cell Tumour (TGCT)?

It's a rare, non-cancerous growth that can happen in the joints, causing pain or swelling.

What is a placebo?

A placebo looks like the study drug but contains no active medicine. It helps compare the new drug's effects fairly.

How long will I be in the study?

The study has three parts. Part 1 is about 24 weeks, Part 2 is another 24 weeks, and Part 3 continues until the study ends or you leave.

Can I stop participating in the study at any time?

Yes, you can choose to leave the study at any point, and your regular medical care will not be affected.

Who is funding this research?

The study is sponsored by the company developing Pimicotinib, which is ABSK Therapeutics.