A Trial of ABSK043, an Oral PD-L1 Inhibitor, in Patients With Angiogenic Sarcomas
ConditionSarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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 criteria
Qualifiers
Be willing and able to provide written informed consent/assent for the trial.
Be >18 years of age on day of signing informed consent.
Intimal sarcoma
Head and neck angiosarcoma
Disqualifiers
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 treatment.
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 is allowed (i.e. less than or equal to prednisone 10mg per day)
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.
Trial design
Treatments tested in this trial
- ABSK043 single agent
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov