drugset / Trial / NCT06191263

Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML

NCT06191263 ↗

Phase 2 Recruiting 98 enrolled Ryvu Therapeutics SA
NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start
2024-01-05
Primary completion
2026-02
Completion
2026-09

Drugs

EvaluationDrugModalityDoseRoute
Subject SEL-120 FREE BASE Small molecule 125 mg Oral
Subject SEL-120 FREE BASE Small molecule 250 mg Oral
Subject Venetoclax Small molecule 200 mg Oral
Subject Venetoclax Small molecule 400 mg Oral