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Study on the Safety and Effects of AMB-05X Injections for Patients with Tenosynovial Giant Cell Tumor

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Tenosynovial Giant Cell Tumor (TGCT). TGCT is a type of tumor that affects the joints, causing pain and stiffness. The treatment being tested in this study is called AMB-05X, which is administered as a solution for injection directly into the joint. The purpose of the study is to evaluate the safety and effectiveness of AMB-05X in treating TGCT.

The study is divided into two parts. In the first part, participants will receive treatment with AMB-05X for 24 weeks. During this time, researchers will monitor how well the treatment works and any side effects that may occur. After the initial treatment period, participants may continue into the second part of the study, which involves extended treatment and observation. This part aims to gather more information on the long-term effects of the treatment.

Throughout the study, participants will undergo various assessments, including imaging tests like MRI scans, to measure the size of the tumor and evaluate the response to the treatment. The study will also track changes in joint movement, pain levels, and overall physical function. By participating in this study, researchers hope to gain valuable insights into the potential benefits of AMB-05X for individuals with TGCT.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study begins with an initial treatment phase lasting 24 weeks. During this period, the patient receives AMB-05X as an injectable solution. This medication is administered directly into the joint affected by the tenosynovial giant cell tumor (TGCT).
The primary goal of this phase is to evaluate the safety and effectiveness of the treatment. The patient's response to the medication is monitored through regular assessments, including imaging tests to measure the size of the tumor.
Step 2
Evaluation of treatment response
At the end of the 24-week initial treatment phase, the patient's response to the treatment is evaluated. This includes determining whether there has been a complete or partial reduction in tumor size, as assessed by imaging tests.
The frequency and severity of any side effects experienced during the treatment are also recorded.
Step 3
Long-term extension phase
Following the initial treatment phase, the patient may enter a long-term extension phase. This phase allows for continued treatment or observation, depending on the patient's response to the initial treatment.
During this phase, the patient may receive additional doses of AMB-05X if necessary. The frequency and duration of these doses are determined based on the patient's individual needs and response to the treatment.
Step 4
Ongoing monitoring and assessments
Throughout the study, the patient undergoes regular monitoring and assessments to track the progress of the treatment. This includes measuring changes in joint function, pain levels, and overall quality of life.
Blood tests and other evaluations are conducted to monitor the levels of AMB-05X in the body and to check for any potential immune responses to the medication.
Step 5
Completion of study participation
Upon completion of the study, the patient's overall response to the treatment is evaluated. This includes a final assessment of tumor size, joint function, and any side effects experienced during the study.
The results of the study contribute to a better understanding of the safety and effectiveness of AMB-05X in treating tenosynovial giant cell tumor.

Who can join the trial?

10 criteria

The patient must have never received **AMB-05X** in another study.
The patient must have a **measurable disease** of at least 1 cm, which is checked using MRI scans.
The patient must be able to understand and agree to follow the study requirements and sign the **informed consent form** before any study procedures begin.
The patient must agree to follow **contraception guidelines** during the study.
The patient must have **adequate hematologic, hepatic, and renal function** at the start of the study. This means their blood, liver, and kidney functions are at acceptable levels.
The patient must have **symptomatic TGCT**, which means they have symptoms like pain or stiffness.
The patient must be at least 18 years old.
The patient must have **TGCT** affecting only one joint, confirmed by a pathologist. If not previously confirmed, a biopsy is needed before joining the study.
If the patient uses prescription pain medication, they must be on a stable regimen for at least 2 weeks before starting the study.
The patient must have a **BPI worst pain score** of at least 4 or a **Worst Stiffness NRS score** of at least 4 before starting the study. These scores measure the level of pain or stiffness the patient experiences.

Who cannot join the trial?

4 criteria

Patients who have a different condition than Tenosynovial Giant Cell Tumor cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population may not be eligible.
Patients who do not meet other specific health criteria set by the study may be excluded.

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Academisch Ziekenhuis Leiden
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Leiden, The Netherlands

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Investigated drugs

AMB-05X is an investigational medication being studied for its potential to treat tenosynovial giant cell tumor (TGCT). This medication is administered through injections directly into the joint (intra-articular) to assess its safety, how well it works, and how the body processes it. The study aims to understand the effects of AMB-05X over an initial 24-week period and during a longer-term extension phase.

Amb-05X

What is already known about the treatment

AMB-05X – This medication is administered through injections directly into the joint, known as intra-articular administration. It is currently being studied in clinical trials for its safety, tolerability, and effectiveness in treating Tenosynovial Giant Cell Tumor (TGCT). The main therapeutic indication for AMB-05X is the treatment of TGCT, a condition characterized by the growth of benign tumors in the joint lining. At the molecular level, AMB-05X works by targeting specific pathways involved in the growth and maintenance of these tumors, potentially reducing their size and impact. It is classified pharmacologically as a targeted therapy, focusing on specific molecular targets associated with the disease.

Investigated diseases

Tenosynovial Giant Cell Tumor – This is a non-cancerous growth that typically occurs in the joints, often affecting the knee or hip. It arises from the synovium, which is the lining of the joint or tendon sheath. The tumor can cause swelling, pain, and reduced joint movement. Over time, it may lead to joint damage if not managed. The condition is characterized by the proliferation of synovial cells and the presence of multinucleated giant cells. It is generally slow-growing but can be locally aggressive, affecting the surrounding tissues.