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

Sponsor
Ryvu Therapeutics SA
Study ID
NCT06191263
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RVU120 — DRUG
    RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19
  • Venetoclax — DRUG
    Venetoclax specifically binds to BCL-2, displacing proapoptotic proteins and triggering events that lead to apoptosis

Study Details

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

Key Dates

Start date
Jan 5, 2024
Status verified
Dec 2024
Primary completion
Feb 28, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
98 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RVU120 + Venetoclax
    RVU120 oral capsule, 125 or 250 mg administered every other day on Days 1-13 of each 21-day cycle of treatment, combined with venetoclax oral tablet, 200 or 400 mg administered once daily on Days 1-14 of each 21-day cycle of treatment

Primary Outcome Measure

(Part 1) recommended doses of RVU120 and venetoclax for further study [ Time Frame: approx. 12 months ]

Central Contacts

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