Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML
Market
0.0%
Details
- Resolved Date
- 6/12/25
- Study Completion
- 9/1/26
- Company
- Ryvu Therapeutics SA
- Ticker
- RVU.WA
- Type
- Trial Status
- Recruiting
- Trial Size
- 98
- Volume
- $0
- NCT
- NCT06191263
- Drug Description
- 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
Resolution Evidence
- Outcome
- YES
- Status
- Resolved
- Settlement Date
- 4/1/26 UTC
- Executive Summary
Sponsor public readouts for the exact Phase II RIVER-81/NCT06191263 trial clearly describe the study as showing promising activity, improved outcomes with optimized dosing, tolerability, and support for further exploration. Later company update also says the trial induced complete remissions with favorable safety.
Sources
Sponsorryvu.com6/12/25
Ryvu Therapeutics Presents Data on RVU120 at the European Hematology Association Congress 2025
For RIVER-81 Phase II, Ryvu said RVU120+venetoclax showed promising anti-leukemic activity; optimized dosing improved results, and the study supports further exploration with tolerated safety.
View source
Sponsorryvu.com11/20/25
Ryvu Therapeutics Reports Third Quarter 2025 Financial Results
Company update states Phase II RIVER-81 data suggest romaciclib restores venetoclax sensitivity in resistant AML, inducing complete remissions with a favorable safety profile.
View source
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