Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML

Exclusion Criteria

• •Active central nervous system (CNS) leukemia.
• •Diagnosis of acute promyelocytic leukemia (APL), the M3 subtype of AML.
• •Previous treatment with CDK8 and/or CDK19-targeted therapy.
• •Major surgery within 28 days prior to first dose of study drug.
• •Hematopoietic stem cell transplant within 120 days prior to first dose of study drug.
• •Active, ≥Grade 2 acute graft versus host disease (GVHD), active moderate-to-severe chronic GVHD, or requirement for systemic immunosuppressive medications for GVHD
• •Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection and acute inflammatory conditions (including pancreatitis).
• •Known seropositivity or history of active viral infection with human immunodeficiency virus (HIV).
• •Ongoing significant liver disease
• •Impairment of gastrointestinal function or gastrointestinal disease
• •Ongoing drug-induced pneumonitis.
• •Concurrent participation in another investigational clinical trial.
• •Taking any medications, herbal supplements, or other substances (including smoking) that may interfere with the metabolism of the study drug
• •Significant cardiac dysfunction defined as myocardial infarction within 12 months of first dose of study drug, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina or left ventricular ejection fraction (LVEF) \<40% as per echocardiography or multiple gated acquisition (MUGA) scan.
• •History of ventricular arrhythmia, or QTc ≥470 ms (Bazett's formula).
• •Prior history of malignancies other than AML, unless the participant has been free of the disease for 5 years or more prior to Screening
• •Pregnant or breast-feeding.