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

Key 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 allconventional 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 PrognosticScoring System (IPSS-R) (score of > 4.5 ie, high or very high) or World HealthOrganization (WHO) 2022 classification (ie, MDS-IB1 or MDS-IB2).

• Refractory or relapsed after hypomethylating agents (HMAs) (such as azacitidine ordecitabine).

Key Exclusion Criteria:

All Participants:

• Diagnosis of acute promyelocytic leukemia (APL).

• Presence of extramedullary AML at screening.

• Prior autologous or allogenic hematopoietic stem cell transplant (HSCT) within 3months prior to initiation of trial treatment.

• Active graft-versus-host disease.

• History of severe immune-related adverse events.

• Treatment with anti-cancer agent (eg, small molecule, antibody, chemotherapy,radiation therapy), or major surgery within 2 weeks prior to the first dose ofGEN3018.

Other protocol-defined Inclusion and Exclusion criteria may apply.