APR-548 in Combination With Azacitidine for the Treatment of TP53 Myelodysplastic Syndromes (MDS)

Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Documented diagnosis of TP53-mutant MDS, according to WHO criteria that is relapsed/refractory or previously untreated MDS. 3. Adequate organ function as defined by the following laboratory values: 1. Creatinine clearance ≥60 mL/min (by Cockcroft-Gault method, Appendix I), 2. Total serum bilirubin ≤1.5 × upper limit of normal (ULN) unless due to Gilbert's syndrome or MDS organ involvement, 3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN, unless due to MDS organ involvement. 4. Age ≥18 years at the time of signing the informed consent form. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Appendix II). 6. Projected life expectancy of ≥12 weeks. 7. Clear ocular media and adequate pupil dilation to permit fundus examination and retinal imaging. Exclusion Criteria: 1. Cardiac abnormalities, which includes, but not limited to: 1. Myocardial infarction within six months prior to enrollment 2. New York Heart Association Class III or IV heart failure or known LVEF \<40% 2. Concomitant malignancies or previous malignancies with less than a 1 year disease-free interval at the time of signing informed consent. 3. Use of cytotoxic chemotherapeutic agents, or experimental agents for the treatment of MDS within 14 days or 5 half-lives of the product (whichever is shorter) of the first day of study drug treatment. 4. Prior exposure to eprenetapopt (APR-246). 5. A female subject who is pregnant or breast-feeding. 6. Known history of human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C infection. 7. Malabsorption syndrome or other condition likely to affect gastrointestinal absorption of APR-548. 8. Known history or current evidence of ocular disease in either eye