CT859: This phase I trial is evaluating an oral drug (IMG-7289) alone and in combination with a non-chemotherapy drug (ATRA) for the treatment of Acute Myeloid Leukaemia (AML) and Myelodysplastic SyndromeA Multi-Center, Open Label Study to Assess the Safety, Steady-State Pharmacokinetics and Pharmacodynamics of IMG-7289 With and Without ATRA (Tretinoin) in Patients With Advanced Myeloid Malignancies

Inclusion

High-risk Acute Myeloid Leukemia (AML)

• Have a diagnosis of AML according to the World Health Organization (WHO) criteria
• Have an Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
• Have AML that is classified as high risk as defined by one of the following: ≥ 60 years of age who were not candidates for or have refused standard chemotherapy; ≥18 years of age with de novo or secondary AML who were not expected to benefit from standard remission-induction chemotherapy; or had relapsed/refractory AML after no more than 3 previous lines of chemotherapy.

High-risk Myelodysplastic Syndromes (MDS)

• Have a diagnosis of myelodysplastic syndromes according to the World Health Organization (WHO) criteria
• Have either an International Prognostic Scoring System (IPSS) score equivalent to intermediate-2 risk or higher, or a Revised International Prognostic Scoring System (IPSS-R) score equivalent to intermediate risk or higher.
• Have MDS that is classified as high risk as defined by one of the following: participants who have failed first-line therapy; or treatment-related MDS, except if it is associated with favorable cytogenetics, and not a candidate for stem cell transplantation
• Prior autologous stem cell transplant is allowed if a minimum of 3 months has elapsed from the time of transplant and the patient has recovered from transplant-associated toxicities
• Prior allogeneic stem cell transplant is allowed, provided all of the following criteria are met: transplant was >120 days prior to study enrollment; no immunosuppressive medications have been taken for at least 1 month; and no active graft versus host disease (GVHD), excluding Grade 1 skin GVHD
• Has a life expectancy >12 weeks