A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

Inclusion Criteria

• •Subject diagnosed with R/R AML or R/R higher risk MDS is defined as:
• •* R/R AML: Morphologically documented primary or secondary AML by the WHO criteria (2016); and refractory to at least 2 cycles of induction chemotherapy/not a candidate for re-induction or relapsed after achieving remission with a prior therapy; and received all standard therapies including targeted therapies (unless the therapy is contraindicated or intolerable) which are known to provide clinical benefit in the opinion of the treating investigator; and received salvage therapy or is not a candidate for salvage therapy.
• •* R/R higher risk MDS: Has MDS by the WHO criteria (2016); and either relapsed after achieving remission or refractory to standard therapies, including ≥ 4 cycles of hypomethylating agents (unless the therapy is contraindicated or intolerable); and is classified as higher risk MDS with a score of \> 3.5 by Revised International Prognostic Scoring System (IPSS-R) in MDS.
• •Subject has an Eastern Cooperative Oncology Group performance status of ≤ 2.
• •Subject must meet the following criteria as indicated on the clinical laboratory tests during screening period:
• •* Serum aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × upper limit of normal (ULN).
• •* Serum total bilirubin ≤ 1.5 × ULN.
• •* Serum creatinine ≤ 1.5 × ULN or an estimated glomerular filtration rate of \> 50 mL/min as calculated by the Modification of Diet in Renal Disease equation.
• •* Platelets ≥ 50,000/μL at cycle 1 day 1 (C1D1) in the dose escalation cohorts only.
• •Subject has a life expectancy of ≥ 12 weeks at the time of screening.
• •Subjects with AML must have peripheral blood absolute blast count of \< 20,000/μL at C1D1. Note: Blast count can be controlled by hydroxyurea during screening period.
• •Female subject is not pregnant and at least 1 of the following conditions apply:
• •* Not a woman of childbearing potential (WOCBP).
• •* WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 180 days after final study treatment administration.
• •Female subject must agree not to breastfeed starting at screening and throughout the study period and for 180 days after the final study treatment administration.
• •Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 180 days after final study treatment administration.
• •Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 180 day after final study treatment administration.
• •Male subject must not donate sperm during the treatment period and for 180 days after the final study treatment administration.
• •Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 180 days after final study treatment administration.
• •Subject agrees not to participate in another interventional study while receiving study treatment in the present study.
• •Subject with left ventricular ejection fraction of \< 45% on echocardiogram or multigated acquisition scan (MUGA) performed within 28 days of screening.
• •Subject has laboratory abnormalities, or clinical evidence of disseminated intravascular coagulation, or ongoing history of coagulation disorder manifested by bleeding or clotting.
• •Subject has an active uncontrolled infection.
• •Subject is known to have human immunodeficiency virus infection.
• •Subject has active hepatitis B or C or other active hepatic disorder.
• •Subject has any condition which makes the subject unsuitable for study participation.
• •Subject has a known or suspected hypersensitivity to bovine-derived protein or has suspected hypersensitivity to any ingredients of ASP7517.
• •Subject is eligible for HSCT.