RecruitingPhase 2NCT07014137

A Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas

A Phase II Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas


Sponsor

University Health Network, Toronto

Enrollment

20 participants

Start Date

Sep 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ABSK043, a new oral pill that works by activating the immune system (an immunotherapy drug) to fight certain rare blood vessel tumors, including intimal sarcoma, head and neck angiosarcoma, and a condition called epithelioid hemangioendothelioma (EHE). **You may be eligible if...** - You are over 18 years old - You have been diagnosed with intimal sarcoma, head and neck angiosarcoma, or EHE that has spread or cannot be surgically removed - Your tumor can be measured on a scan - You are well enough to carry out daily activities (ECOG score 0, 1, or 2) - You can swallow pills **You may NOT be eligible if...** - You have a weakened immune system or are on immune-suppressing medications - You have previously received immunotherapy drugs targeting similar pathways (anti-PD-1/PD-L1) - You have received other cancer treatments recently without recovering from their side effects - You have another active cancer diagnosis within the last 3 years - You have an active gastrointestinal condition that could affect drug absorption Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABSK043 single agent

ABSK043 BID continuously for 28 day cycle


Locations(1)

UHN- Princess Margaret Cancer Center

Toronto, Ontario, Canada

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NCT07014137


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