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New treatment option for Sarcoma
Official title A Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas
ClinicalTrials.gov ID: NCT07014137
What this study is testing
What is ABSK043 single agent?
ABSK043 single agent is an investigational medicine, being studied as a potential treatment for sarcoma.
Also referred to as ABSK043.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- ABSK043 is a new type of experimental drug that blocks a protein called programmed cell death ligand 1 (PD-L1), which is important in controlling the body's response to harmful substances including cancer cells. By blocking PD-L1 from working, ABSK043 may allow the body's immune system to recognize and kill cancer cells.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be willing and able to provide written informed consent/assent for the trial.
- Be \>18 years of age on day of signing informed consent.
- Have one of the following advanced (unresectable and/or metastatic) solid tumor indications:
- Intimal sarcoma
- Head and neck angiosarcoma
You likely can't join if
- The subject must be excluded from participating in the trial if the subject:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used...
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to...
- Has had prior treatment with any anti-PD-1, anti-PD-L1 or other antibodies specifically targeting the immune checkpoint pathways.
- Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from...
- Has active gastrointestinal condition that may affect the absorption of ABSK043, according to investigator.
See the full eligibility criteria
Who can join
- Be willing and able to provide written informed consent/assent for the trial.
- Be \>18 years of age on day of signing informed consent.
- Have one of the following advanced (unresectable and/or metastatic) solid tumor indications:
- Intimal sarcoma
- Head and neck angiosarcoma
- Epithelioid hemangioendothelioma (EHE)
- Have measurable disease based on RECIST v1.1.
- Have a performance status of 0, 1, or 2 on the ECOG Performance Scale.
- Have the ability to swallow and retain orally administered medications.
- Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 10 days of treatment initiation.
- Female subject of childbearing potential should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication.
- Female people of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last...
- Male people should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
What rules you out
- The subject must be excluded from participating in the trial if the subject:
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of...
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Use of steroids at physiological dose...
- Has had prior treatment with any anti-PD-1, anti-PD-L1 or other antibodies specifically targeting the immune checkpoint pathways.
- Has had a prior anti-cancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has active gastrointestinal condition that may affect the absorption of ABSK043, according to investigator.
- Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously...
- Note: people with ≤ Grade 2 neuropathy or alopecia are an exception to this criterion and may qualify for the study.
- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Has a known additional malignancy within the last 3 years or continues to receive antineoplastic treatment after curative intent surgery. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of...
- Has known active central nervous system (CNS) metastases and/or leptomeningeal disease. people with previously treated brain metastases may participate provided they are stable (without evidence of progression by...
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine...
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has evidence of interstitial lung disease.
- Has an active infection requiring systemic treatment.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial...
- Has a known history of Human Immunodeficiency Virus (HIV) with detectable viral load.
- Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected).
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds (ms)).
- A history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- The use of concomitant medications that prolong the QT/QTc interval.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. 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 ClinicalTrials.gov; the study team decides eligibility.