Actively Recruiting
A Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas
Led by University Health Network, Toronto · Updated on 2025-09-11
20
Participants Needed
1
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. ABSK043 is considered "experimental" because it has not been approved for sale by Health Canada. Health Canada has approved the study drug to be administered in this research study. The main purposes of this study are: * To see if patients with your type of cancer benefit from ABSK043. * To evaluate the safety and tolerability of ABSK043. * To identify biomarkers (Biological flags used to measure disease progress or drug effect.) in tumor tissues or blood that might help identify patients whose cancers respond to ABSK043, and which patients may develop side effects from these study drugs. Examples of biomarkers include the type of white blood cells in your tumor or proteins in your blood. It is anticipated that about 20 people will take part in this study from the Princess Margaret Cancer Centre.
CONDITIONS
Official Title
A Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent or assent for the trial
- Age over 18 years at the time of signing consent
- Diagnosed with advanced (unresectable and/or metastatic) intimal sarcoma, head and neck angiosarcoma, or epithelioid hemangioendothelioma (EHE)
- Measurable disease according to RECIST version 1.1
- ECOG performance status of 0, 1, or 2
- Ability to swallow and retain oral medications
- Adequate organ function as defined in the trial within 10 days before starting treatment
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Female participants of childbearing potential must use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for 120 days after last dose
- Male participants must agree to use adequate contraception from first dose through 120 days after last dose
You will not qualify if you...
- Participation in another investigational study or use of investigational therapy or device within 4 weeks before starting treatment
- Diagnosis of immunodeficiency or use of systemic steroids or immunosuppressive therapy within 7 days before first dose (physiological steroid doses allowed)
- Prior treatment with anti-PD-1, anti-PD-L1, or other immune checkpoint antibodies
- Prior anti-cancer monoclonal antibody treatment within 4 weeks before study start or unresolved adverse events from earlier treatments
- Active gastrointestinal conditions affecting absorption of ABSK043
- Chemotherapy, targeted therapy, or radiation within 2 weeks before study start or unresolved side effects, except for certain mild neuropathy or alopecia
- Recent major surgery without adequate recovery
- Additional malignancies within last 3 years except certain skin cancers or in situ cervical cancer
- Active central nervous system metastases or leptomeningeal disease; stable treated brain metastases allowed without steroids
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or signs of non-infectious pneumonitis or interstitial lung disease
- Active infection requiring systemic treatment
- Any condition or abnormality that may interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant or breastfeeding, or planning to conceive or father children during study and 120 days after last dose
- Known HIV with detectable viral load
- Active Hepatitis B or Hepatitis C infection
- Prolonged QT/QTc interval or risk factors for torsades de pointes
- Use of medications that prolong QT/QTc interval
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UHN- Princess Margaret Cancer Center
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
Research Team
A
Albiruni Razak, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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