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Study on the Safety and Effectiveness of ABSK021 for Patients with Tenosynovial Giant Cell Tumor

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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). This is a type of tumor that affects the joints and can cause pain and stiffness. The study is testing a new treatment called ABSK021, which is taken as a capsule. The purpose of the study is to determine if ABSK021 is safe and effective in treating TGCT.

Participants in the study will be randomly assigned to receive either the ABSK021 treatment or a placebo. The study will last for up to 48 weeks, during which participants will take the medication and attend regular check-ups. These check-ups will help researchers monitor the effects of the treatment on the tumor and any changes in symptoms like joint movement, stiffness, and pain.

The study aims to see how well the treatment works by measuring the size of the tumor and assessing improvements in joint function and quality of life. Participants will be closely monitored to ensure their safety throughout the study. The results will help determine if ABSK021 can be a beneficial treatment option for people with Tenosynovial Giant Cell Tumor.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization

    Upon joining the study, participants are randomly assigned to receive either the study drug ABSK021 or a placebo. This process is double-blind, meaning neither the participant nor the study team knows which treatment is being administered.

  2. Step 2

    Treatment administration

    Participants take the assigned treatment orally in the form of a capsule. The specific dosage and frequency are determined by the study protocol and are followed throughout the trial period.

  3. Step 3

    Treatment duration

    The treatment is administered over a period of 25 weeks. During this time, participants are monitored for any changes in their condition and any side effects.

  4. Step 4

    Evaluation of response

    The primary goal is to assess the Objective Response Rate (ORR) within 25 weeks, based on specific criteria. This involves measuring the size of the tumor and evaluating any changes.

  5. Step 5

    Secondary assessments

    Additional assessments include changes in joint movement, stiffness, pain levels, and overall physical functioning. These are measured using various scales and questionnaires.

  6. Step 6

    End of treatment evaluation

    At the end of the 25-week period, a comprehensive evaluation is conducted to determine the overall effectiveness of the treatment and any lasting effects.

Who can join the trial?

7 criteria

  • Patients should understand the study procedures and sign the informed consent form before the screening process begins.
  • Patients must be **18 years or older**.
  • Patients must have a **histologically confirmed** Tenosynovial Giant Cell Tumor (TGCT) that cannot be treated with surgery before the study starts. **Histologically confirmed** means that the diagnosis was made by examining tissue under a microscope.
  • Patients must have a **measurable disease** as defined by RECIST 1.1, with at least one tumor or lesion that is **2 centimeters or larger** before the study starts. **Measurable disease** means that the tumor can be measured in size.
  • Patients who need pain medication must have a stable prescription for their pain medication during the 2 weeks before the study starts.
  • Patients should complete stiffness and pain scales during the screening period, and their symptoms due to active TGCT should meet the minimum requirements as outlined in the study protocol.
  • Patients must have **adequate organ function** and **bone marrow function**. This means their organs and bone marrow, which is the soft tissue inside bones, are working well enough to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients who have a different condition than Tenosynovial Giant Cell Tumor cannot participate. This is a specific type of tumor that affects the lining of joints and tendons.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study organizers.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

ABSK021 is a medication being studied for its effectiveness and safety in treating patients with Tenosynovial Giant Cell Tumor (TGCT). This trial aims to determine how well ABSK021 works in reducing the size of the tumor and improving symptoms in patients over a period of 25 weeks. The study compares the results of patients taking ABSK021 to those who do not receive the active medication.

What is already known about the treatment

ABSK021 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating Tenosynovial Giant Cell Tumor (TGCT). It is in the Phase 3 stage of clinical trials, which means it is being tested for efficacy and safety in a larger group of patients. The main therapeutic indication for ABSK021 is the treatment of TGCT, a type of tumor that affects the synovial lining of joints and tendons. At the molecular level, ABSK021 works by inhibiting specific pathways that contribute to tumor growth and proliferation. It is classified pharmacologically as a targeted therapy, aiming to interfere with specific molecules involved in the growth and spread of cancer cells.

Investigated diseases

Tenosynovial Giant Cell Tumor – This is a rare, non-cancerous tumor that typically affects the synovium, bursae, and tendon sheaths. It often occurs in the joints, most commonly in the knee or hip, and can cause swelling, pain, and reduced joint movement. The tumor grows slowly and can vary in size, sometimes becoming large enough to cause significant discomfort or joint dysfunction. It is characterized by the overgrowth of the synovial tissue, which can lead to joint damage if left untreated. The condition is more prevalent in young to middle-aged adults and can affect both men and women. Although benign, it can recur after surgical removal, necessitating careful monitoring.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503245-58-00Protocol codeABSK021-301Estimated enrolment93 patientsSponsorAbbisko Therapeutics Co. Ltd.

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