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A clinical study of ABSK021 in Patients with Tenosynovial Giant Cell Tumor to determine whether the study drug is safe and how well the antitumor activity of study drug
EU CTIS ID: 2023-503245-58-00
What this study is testing
To compare the Objective Response Rate (ORR) within 25 weeks after treatment with ABSK021 or placebo in TGCT patients based on RECIST 1.1.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients should understand the study procedures and sign the informed consent form prior to screening
- Age ≥ 18 years
- A histologically confirmed TGCT with not amenable to surgery prior to randomization.
- Measurable disease as defined by RECIST 1.1, and with at least one lesion of ≥ 2 cm prior to randomization.
- Stable prescription of analgesic regimen for patients with an analgesic need during the 2 weeks prior to randomization.
- Participants should complete stiffness and pain scales during the screening period, and symptomatic disease because of active TGCT should meet minimum requirements as outlined in study protocol.
You likely can't join if
- Known allergy or hypersensitivity to any components of the investigational drug product
- Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R prior to randomization. However, patients who have received prior treatment with multi-kinase inhibitors that include the CSF-1/CSF-1R pathway are allowed, such as Imatinib and Nilotinib
- Known additional malignancy that required active treatment and may affect the patient’s participation in the study or affect the outcome of the study as assessed by the Investigator
- Known metastatic TGCT
- Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization, or unhealed, infected, or dehiscence of previous surgical wounds, or adverse events from prior therapies did not recover to ≤ Grade 1 (CTCAE 5.0).
- Impaired cardiac function or clinically significant cardiac disease
See the full eligibility criteria
- Patients should understand the study procedures and sign the informed consent form prior to screening
- Age ≥ 18 years
- A histologically confirmed TGCT with not amenable to surgery prior to randomization.
- Measurable disease as defined by RECIST 1.1, and with at least one lesion of ≥ 2 cm prior to randomization.
- Stable prescription of analgesic regimen for patients with an analgesic need during the 2 weeks prior to randomization.
- Participants should complete stiffness and pain scales during the screening period, and symptomatic disease because of active TGCT should meet minimum requirements as outlined in study protocol.
- Adequate organ function and bone marrow function.
- Known allergy or hypersensitivity to any components of the investigational drug product
- Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R prior to randomization. However, patients who have received prior treatment with multi-kinase inhibitors that include the CSF-1/CSF-1R pathway are allowed, such as Imatinib and Nilotinib
- Known additional malignancy that required active treatment and may affect the patient’s participation in the study or affect the outcome of the study as assessed by the Investigator
- Known metastatic TGCT
- Major surgery or previous anti-tumor therapy for TGCT within 4 weeks prior to randomization, or unhealed, infected, or dehiscence of previous surgical wounds, or adverse events from prior therapies did not recover to ≤ Grade 1 (CTCAE 5.0).
- Impaired cardiac function or clinically significant cardiac disease
- Known active liver or biliary disease, or other diseases that may lead to abnormal liver function test results during the study.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.