Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Open-Label, Adaptive, Dose-Ranging Study with Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra-articular AMB-05X Injections in Subjects with Tenosynovial Giant Cell Tumor

This research study is looking into a new medicine, AMB-05X, for people with Tenosynovial Giant Cell Tumor (TGCT). It's a 'Phase 2' study, which means it's still in the earlier stages of testing in humans, focusing on finding the right dose and understanding its effects. The main goals are to check if AMB-05X is safe, if people can tolerate it without too many side effects, and if it helps by shrinking the tumor. Researchers will also look at how the medicine moves through the body. This study includes a long-term plan to follow participants. If you have TGCT, this study could be an opportunity to try a new treatment while helping doctors learn more about the condition and how to treat it.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ammax Bio Inc.

Enrolment target

Start

06 Oct 2023

Tenosynovial Giant Cell Tumor

What is this study about?

This study is designed to explore a new potential treatment, AMB-05X, for a condition called Tenosynovial Giant Cell Tumor, often shortened to TGCT. TGCT is a rare type of tumor that grows in the soft tissue around joints, most commonly in the knee or hip, and it can cause pain, swelling, and limit movement.

This specific study is in 'Phase 2'. This stage of research is all about learning more about a new medicine after initial safety tests. The doctors want to find out the best amount of AMB-05X to give (the 'dose'), how often it should be given, and generally how safe and well-tolerated it is for people with TGCT. They will also be carefully watching to see if the medicine helps to shrink the tumors. This information is really important for deciding if the medicine should move forward to larger studies.

The researchers will be monitoring participants closely in a few key ways. A major focus is on whether the tumor gets smaller, which will be checked using detailed scans. They'll also be tracking any side effects experienced by participants, assessing how much pain and stiffness participants have, and looking at how well participants can move their joints and perform everyday activities. The study will involve a long-term follow-up to continue observing the medicine's effects over time.

Key takeaways

This study is for people with Tenosynovial Giant Cell Tumor (TGCT).
It's testing a new medicine called AMB-05X.
The main goals are to check safety, side effects, and if the medicine shrinks the tumor.
Participants will receive the active medicine (no placebo).
It's a Phase 2 study, meaning it's an earlier stage of testing in humans.
Participation involves clinic visits, injections, scans, and questionnaires.

Who may be eligible?

To join this study, you would generally need to be an adult, 18 years of age or older. Both men and women are welcome to participate.

However, there will be other specific health requirements that you would need to meet. For example, doctors will check your overall health and if you have certain other medical conditions, as these might affect whether the treatment is suitable or safe for you. They will also look at your specific diagnosis of Tenosynovial Giant Cell Tumor.

It's important to remember that these are just general guidelines. A dedicated study doctor will carefully review your full medical history and perform some tests to determine if this study is the right fit for you. They will explain everything clearly.

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 a confirmed diagnosis of Tenosynovial Giant Cell Tumor (TGCT)?
Are you able to attend regular clinic visits and appointments?
Are there any other serious health conditions you have that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, AMB-05X, through injections into the affected joint. You would have a series of visits to the clinic for medical check-ups, to receive your medication, and for various assessments. These assessments would likely include physical examinations, blood tests, and imaging scans (like MRI scans) to measure the size of your tumor.

Doctors would also ask you to complete questionnaires about your pain levels, stiffness, and how well you can move and do your daily activities. Your participation would be carefully monitored, and you would be followed for a long time, even after the main treatment period, to understand the long-term effects of the medicine. The total length of your participation would be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of joining this study could be receiving a new investigational medicine, AMB-05X, for your Tenosynovial Giant Cell Tumor, which may help shrink your tumor and improve your symptoms. However, as this is an experimental medicine, there's also a chance it may not help you, or you might experience side effects. These side effects, also known as adverse events, will be carefully monitored by the study team. You will be given a full explanation of all known potential risks before you agree to participate. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Tenosynovial Giant Cell Tumor (TGCT)?

TGCT is a rare type of growth that forms in the soft tissue around joints, often causing pain, swelling, and problems with movement.

What is AMB-05X?

AMB-05X is a new medicine being tested to see if it can help treat Tenosynovial Giant Cell Tumor.

Why is this study important?

This study aims to find out if AMB-05X is safe and effective in shrinking TGCT and improving symptoms, which could lead to a new treatment option.

Will I get the actual medicine or a placebo (dummy treatment)?

This is an 'open-label' study, meaning everyone who participates will receive the active study medicine, AMB-05X, not a placebo.

How long will I be in the study?

The study involves an initial treatment period and then a long-term follow-up. The full duration will be explained by the study team.