First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)

Inclusion Criteria

• •All Participants:
• •Be at least 18 years of age at the time of signing informed consent form (ICF).
• •Participant's life expectancy at screening is judged to be at least 3 months.
• •Must have fresh bone marrow samples collected at screening.
• •Bone marrow (BM) blasts ≥ 5% at screening.
• •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2.
• •Has acceptable laboratory test results during the screening period
• •Participants with R/R AML:
• •Relapsed or refractory AML, either de novo or secondary, and must have failed all conventional therapies.
• •Relapsed or refractory to at least one prior line of therapy.
• •Participants with R/R HR-MDS:
• •Diagnosed with high- or very-high risk MDS according to International Prognostic Scoring System (IPSS-R) (score of \> 4.5 ie, high or very high) or World Health Organization (WHO) 2022 classification (ie, MDS-IB1 or MDS-IB2).
• •Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine or decitabine).