Ongoing Clinical Trials for Giant Cell Tumour Of Tendon Sheath
There are currently 2 ongoing clinical trials investigating new treatments for Giant Cell Tumour Of Tendon Sheath (also known as: Tenosynovial Giant Cell Tumor, TGCT). These studies are testing targeted therapies that aim to reduce tumor size and improve joint function, pain, and stiffness in patients for whom surgery is not a suitable option. The trials are being conducted across multiple European countries including Austria, Belgium, France, Italy, the Netherlands, Poland, Spain, and Sweden.
Clinical trial locations
- Austria
- Belgium
- France
- Italy
- Netherlands
- Poland
- Spain
- Sweden
Study of emactuzumab compared to placebo in patients with tenosynovial giant cell tumor
This study is investigating emactuzumab, a medication given through intravenous infusion, for the treatment of Giant Cell Tumour Of Tendon Sheath. The trial compares emactuzumab to placebo to determine whether it can effectively reduce tumor size and improve symptoms over a 6-month period.
Main inclusion criteria:
- Confirmed diagnosis through biopsy where surgery is not recommended due to risks of joint function limitations, high chance of tumor returning, or other health concerns
- Tumor must be measurable with a size of at least 20 millimeters
- Age of at least 12 years and body weight of at least 30 kilograms
- Average pain score of at least 4 out of 10 during the week before starting the study
- Average stiffness score of at least 4 out of 10 during the week before starting the study
- Adequate blood test results showing healthy organ and bone marrow function
- Women of childbearing potential must use effective birth control during treatment and for 7 months afterward
Main exclusion criteria:
- Pregnant or breastfeeding women
- History of other cancers within the past 5 years, with some exceptions
- Active infections requiring systemic treatment
- Serious heart conditions including uncontrolled high blood pressure or recent heart attack
- Severe liver or kidney disease
- Known allergies to the study medication
- Active autoimmune diseases requiring immunosuppression
Focus and goals: The main goal is to evaluate how well emactuzumab works in treating this condition by measuring the rate at which tumors respond to treatment within 6 months. During the study, participants undergo regular assessments that track pain levels, joint stiffness, and physical function. Magnetic resonance imaging is used to monitor changes in the tumors. The treatment period may last up to 10 months, with an initial 6-month phase where participants receive either emactuzumab or placebo. If the disease progresses after the initial phase, eligible adult participants may have the option to receive emactuzumab in an open-label phase.
Investigational drug: Emactuzumab is a monoclonal antibody that works by blocking a specific protein called CSF1R on the surface of tumor cells, which helps to reduce tumor growth and associated symptoms. It is administered through intravenous infusion and represents a targeted therapy approach for this rare joint tumor condition.
Study on the Safety and Effectiveness of ABSK021 for Patients with Tenosynovial Giant Cell Tumor
This clinical trial is testing ABSK021, a medication taken as an oral capsule, to determine whether it is safe and effective in treating Giant Cell Tumour Of Tendon Sheath. Participants are randomly assigned to receive either ABSK021 or a placebo over a treatment period of 25 weeks.
Main inclusion criteria:
- Must be 18 years of age or older
- Confirmed diagnosis through tissue examination under a microscope, where surgery is not a suitable treatment option
- Measurable disease with at least one tumor that is 2 centimeters or larger
- If taking pain medication, must have a stable prescription for 2 weeks before the study starts
- Symptoms of pain and stiffness must meet minimum requirements outlined in the study protocol
- Adequate organ and bone marrow function, meaning these systems are working well enough to participate safely
Main exclusion criteria:
- Patients with a different condition than Giant Cell Tumour Of Tendon Sheath
- Patients outside the specified age range
- Patients who are part of vulnerable populations requiring special protection or care
Focus and goals: The primary objective is to assess the Objective Response Rate within 25 weeks by measuring tumor size and evaluating any changes. The study also evaluates secondary outcomes including changes in joint movement, stiffness, pain levels, and overall physical functioning using various scales and questionnaires. Participants attend regular check-ups throughout the 48-week study period to monitor the effects of treatment on the tumor and symptoms, with comprehensive evaluations conducted at the end of the 25-week treatment period.
Investigational drug: ABSK021 is an oral medication currently in Phase 3 clinical trials. It is classified as a targeted therapy that works by inhibiting specific pathways involved in tumor growth and proliferation. The medication aims to interfere with specific molecules that contribute to the growth and spread of tumor cells.
Summary
Both ongoing clinical trials for Giant Cell Tumour Of Tendon Sheath are focused on patients for whom surgery is not a suitable treatment option. The studies are investigating two different targeted therapies: emactuzumab, administered intravenously, and ABSK021, taken orally. Both medications work by targeting specific molecular pathways involved in tumor growth.
The trials share similar goals of reducing tumor size and improving symptoms such as pain, stiffness, and joint function. Both studies use placebo comparisons and require participants to have measurable tumors and significant symptoms at baseline. The geographic distribution of these trials is concentrated in Western and Central Europe, with France, Italy, the Netherlands, Poland, and Spain hosting both studies, providing broader access to these experimental treatments across the region.
These trials represent important research efforts for this rare condition, offering potential new treatment options for patients who cannot undergo surgical removal of their tumors.
