Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML
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.
Timeline
- Start
- 2024-01-23
- Primary completion
- 2026-02
- Completion
- 2026-09
Outcome
Missed primary endpoint
release “As predefined efficacy criteria were not met, the trial did not advance to Part 2, and enrollment was suspended.” ryvu.com ↗
release “Despite relevant blast reductions in some patients, no durable CRs were observed, and enrollment was suspended.” ryvu.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SEL-120 FREE BASE | Small molecule | 250 mg | Oral |