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

Exclusion criteria

• . 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.
• . 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 administered agent.
• . 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 the skin that has undergone potentially curative therapy or in situ cervical cancer.
• . Has known active central nervous system (CNS) metastases and/or leptomeningeal disease. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include leptomeningeal disease which is excluded regardless of clinical stability.