A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes

Inclusion Criteria:

• Participants is ≥ 18 years of age at the time of signing the Informed Consent Form (ICF).

• Participants must understand and voluntarily sign an ICF prior to any study-relatedassessments/procedures being conducted.

• Participants are willing and able to adhere to the study visit schedule and otherprotocol requirements.

• Participants with histologically or cytologically confirmed AML including de novoAML or secondary AML transformed from MDS according to 2022 World HealthOrganization (WHO) criteria classification, or with histologically or cytologicallyconfirmed HR-MDS.

• R/R AML and R/R HR-MDS who have failed or are ineligible for all available therapieswhich may provide clinical benefit.

• Participants must have the following screening laboratory values:

• Total white blood cell count (WBC) < 25 x 10^9/L prior to the first dose of thestudy drug.

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 ×upper limit of normal (ULN), unless considered due to extensive leukemic liverinvolvement, in which case AST and ALT can be ≤ 5.0 x ULN.

• Serum total bilirubin ≤ 1.5 x ULN, unless considered due to Gilbert's syndrome,in which case serum total bilirubin < 3 x ULN.

• Estimated serum creatinine clearance of ≥ 60 mL/min using the Cockcroft-Gaultequation. Measured creatinine clearance from a 24-hour urine collection isacceptable if clinically indicated.

• International normalized ratio (INR) ≤ 1.5 x ULN and active partialthromboplastin time (aPTT) ≤ 1.5 x ULN.

• Life expectancy ≥ 12 weeks.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

• Female Participants of child-bearing potential must have a negative serum or urinepregnancy test at screening and at pre-dose on Cycle 1 Day 1 (C1D1).

Exclusion Criteria:

• Participants with acute promyelocytic leukemia (APML).

• Participants with known leukemic involvement in central nervous system (CNS).

• Receipt of anticancer medications/therapies within 5 half-lives or 28 days beforethe first administration of the study drug.

• Participants with unresolved clinically significant non-hematologic toxicities of ≥Grade 2 AE from prior therapies with exception of residual alopecia.

• Participants with chronic graft versus host disease (GVHD) requiring systemicimmunosuppressive therapy.

• Participants with active malignancies other than AML or MDS.

• Participants who have undergone major surgery ≤ 4 weeks prior to the first dose ofthe study drug.

• Participants with immediately life-threatening, severe complications of leukemiasuch as disseminated/uncontrolled infection (bacterial and/or fungal), uncontrolledbleeding, and/or uncontrolled disseminated intravascular coagulation.

• Participants with known chronic, active infection of hepatitis B virus (HBV),hepatitis C virus C (HCV), human immunodeficiency virus (HIV).

• Participants unable to swallow oral medications, or Participants with clinicallysignificant diarrhea, vomiting or malabsorption felt limited absorption of orallyadministered medications.

• Participants with any other significant medical conditions, any other conditions,laboratory abnormality, or psychiatric illness which place the Participants atunacceptable risk if he/she were to participate in the study or that would hamperthe Participants understanding of the study, or would prevent the Participant fromcomplying with the study.

• Medications or supplements that are known to be strong and moderate inhibitors orinducers of CYP450 isozyme 3A4 (CYP3A4) and/or P-glycoprotein (P-gp), or stronginhibitors or inducers of CYP450 isozyme 2C8 (CYP2C8) within 14 days or 5half-lives, whichever is shorter, before the first dose of study drug.

• Pregnant or lactating women.