Clinical Trial

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

Study acronym: RIVER-52
Active, Not Recruiting Phase 2
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Record status
This record was last updated May 8, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-02-12; most recent amendment 2025-05-07.
Status change: Recruiting → Active, Not Recruiting 2025-05-07
Trial Details
NCT Number NCT06268574
Lead Sponsor Ryvu Therapeutics SA
Conditions Acute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome
Enrollment 94 participants
Start Date 2024-01-23
Primary Completion 2026-02 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-05-08