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

NCT06268574 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-05-08

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia (AML)
  • High-risk Myelodysplastic Syndrome

Interventions

DRUG

RVU120

RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19

Sponsors & Collaborators

  • Ryvu Therapeutics SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-23
Primary Completion
2026-02-28
Completion
2026-09-30

Countries

  • France
  • Italy
  • Poland
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268574 on ClinicalTrials.gov