Etude de phase I/II, en ouvert, d’escalade de doses, comprenant une cohorte preuve-de-concept pour évaluer la sécurité, la tolérance et l’efficacité de l’ARGX-110 en combinaison avec l’azacytidine chez des sujets atteints de leucémie aigüe myéloïde (LAM) ou d’un syndrome myélodysplasique (MDS) à haut risque nouvellement diagnostiqués.

Drug: ARGX-110;Drug: AZA

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Signed informed consent form (ICF) indicating an understanding of the purposes, risks,
and procedures required for the study and willingness and ability to participate in
the study

- Acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS) (according to
2016 World Health Organization [WHO] classification definition of greater than or
equal to [>=] 20 percent [%] blasts) (bone marrow) unsuitable for intensive treatment
(including stem cell transplantation) with a curative intent, but eligible to receive
azacytidine (AZA) treatment

- Expected life expectancy >= 3 months, at the discretion of the investigator

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Women of childbearing potential having a negative serum pregnancy test at screening
and within 48 hours before infusion of ARGX-110 on Day -14, and willing to use an
effective contraceptive method (intrauterine devices, hormonal contraceptives,
contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions
with prolonged release) during the study and for at least 3 months after the last
study drug administration

Exclusion Criteria:

- Prior or concurrent malignancy, except for the following: (1) adequately treated basal
cell or squamous cell skin cancer; (2) carcinoma in situ of the cervix; (3) carcinoma
in situ of the breast; (4) incidental histological finding of Prostate cancer (Tumour,
Node, Metastasis [TNM] stage T1a or T1b), or; (5) Any other cancer from which the
subject has been disease-free for more than 2 years

- Any previous AML or MDS chemo- or radiotherapy (with the exception of
hydroxyurea/Litalir for leukocyte control which should be discontinued by the first
day of AZA, local radiation therapy, therapy for basal or squamous cell carcinoma of
the skin)

- Treatment with any investigational product within 4 weeks before the first
administration of ARGX-110

- Any known active or chronic infection, including human immunodeficiency virus (HIV)
and hepatitis B or C virus infection

- Any other concurrent disease or medical condition that is likely to interfere with
study procedures or results, or that in the opinion of the investigator would
constitute a hazard for participating in this study