A Multicenter, Open-Label, Dose-Finding Clinical Trial to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of RVU120 in Combination With Venetoclax in Participants With Acute Myeloid Leukemia Who Failed Prior Therapy With Ventoclax and a Hypomethylating Agent
The goal of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with acute myeloid leukemia (AML) who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study consists of three parts. Part 1 aims to identify the doses of RVU120 and venetoclax that are considered to be safe and tolerated. Part 2 will assess the safety and efficacy of the doses selected. And Part 3 is a confirmatory cohort where patients will be treated at the same doses assessed in Part 2
• Patients must have a diagnosis of AML (per 2022 WHO classification)
• Patients must have relapsed or refractory AML (per ELN 2022 criteria)
• Patients must have failed first-line treatment with venetoclax combined with a hypomethylating agent
• Patients must have no alternative therapeutic options likely to produce clinical benefit
• Patients must have ECOG performance status of 0 to 2
• Patients must have adequate end organ function defined as:
‣ WBC \< 25 x 10(9)/L on Day 1 prior to first dose of study drug
⁃ Platelet count \> 10,000/mcL on Day 1 prior to first dose of study drug
⁃ AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal)
⁃ Total bilirubin ≤ 3 x ULN
⁃ Creatinine clearance (Cockcroft \& Gault formula) ≥ 50 mL/min
⁃ LVEF (left ventricular ejection fraction) ≥ 40% by electrocardiography
• Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures