A Phase II Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas
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.
• 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 subjects 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 dose of study medication (Reference Section 7.1.4.3). Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
⁃ Male subjects 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.