Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML
ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRyvu Therapeutics SA
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
APL (acute promyelocytic leukemia), the M3 subtype of AML
Active CNS (central nervous system) leukemia
Previous treatment with CDK8 and/or CDK19-targeted therapy
Major surgery within 28 days prior to the first dose of study drug
Trial design
Treatments tested in this trial
- RVU120
- Venetoclax
Treatment groups
98 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov