RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

This first-in-human study will evaluate RVU120 (SEL120), a novel small molecule CDK8/19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (HR-MDS), in terms of selection of the recommended dose for further clinical development and assessment of safety, tolerability, preliminary anti-leukemic activity, as well as pharmacokinetic and pharmacodynamic profiles.

Inclusion Criteria: All the following criteria must be met for a patient to be eligible for the study: 1. Written informed consent provided prior to any study-related procedure. 2. Age ≥18 years. 3. AML diagnosis according to the 2016 World Health Organisation (WHO) classification (Arber et al. 2016) with relapsed or refractory disease with no available therapy who have exhausted the applicable standard of care; or Myelodysplastic Syndrome (MDS) diagnosis according to the 2016 WHO classification (Arber et al. 2016) with high-risk disease per the Revised International Prognostic Scoring System (IPSS-R \>4.5) and with relapsed or refractory disease with no available therapy who have exhausted the applicable standard of care. 4. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2. 5. Patients must have been off anti-cancer treatment prior to study. 6. Patients must have recovered from the toxic effects of previous treatments. 7. Peripheral white blood cell (WBC) count \10,000/μL; Serum albumin ≥ 30g/L (3.0g/dL); Normal coagulation (elevated INR, prothrombin time or APTT \