A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Max-40279-01 in Combination With Azacitidine (AZA) in Patients With Myelodysplastic Syndrome (MDS) or Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Inclusion Criteria:

1. Males and/or females over age 18
2. A diagnosis of AML according to the World Health Organization (WHO) 2016 criteria withrelapsed or refractory disease and have exhausted, or are ineligible for therapeuticoptions, or int-risk or high-risk or very high-risk MDS according to revisedInternational Prognostic Scoring System (IPSS-R);
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
4. Expected survival >3 months.
5. No radiotherapy, surgery or hormonal therapy for any kind of within 2 weeks prior toparticipating in this study. Patients must have fully recovered from the acutetoxicities of any prior treatment with any anti-cancer drugs (includinghypomethylating agents in MDS patients), radiotherapy or other anti-cancer modalities (i.e., returned to baseline status as noted before most recent treatment) for anytumors. Patients with persisting, stable chronic toxicities from such prior treatment ≤Grade 1 are eligible, but must be documented as such.
6. Signed informed consent form.

Exclusion Criteria:

1. Acute promyelocytic leukemia according to World Health Organization 2016 criteria
2. Known central nervous system involvement
3. Medical history of difficulty swallowing, malabsorption or other chronicgastrointestinal disease, or conditions that may hamper compliance and/or absorptionof the tested product
4. Known allergies, hypersensitivity, or intolerance to Max-40279-01 or AZA or theexcipients of these treatments
5. Previously treated malignancies other than the current disease, except for adequatelytreated non-melanoma skin cancer, in situ cancer, or other cancer from which thesubject has been disease-free for at least 5 years at the trial entry