RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis

Sponsor
Ryvu Therapeutics SA
Study ID
NCT06397313
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myelofibrosis

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
  • Ruxolitinib — DRUG
    Ruxolitinib is a kinase inhibitor which inhibits Janus Associated Kinases (JAKs) JAK1 and JAK2

Study Details

The objective of this clinical trial is to evaluate the efficacy (how well the drug works), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug, RVU120, in treating adult patients with intermediate or high-risk, primary or secondary myelofibrosis. RVU120 will be given as a single agent or in combination with ruxolitinib.

Key Dates

Start date
Sep 19, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
230 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RVU120
    Cohort 1 RVU120 is administered at 250 mg as a single agent every other day on days 1, 3, 5, 7, 9, 11, and 13 of 21-day treatment cycles, or at an adjusted dose, to participants with intermediate or high-risk, primary or secondary MF who have been previously treated with or are ineligible for treatment with a JAK inhibitor.
  • Experimental: RVU120 + ruxolitinib
    Cohort 2 RVU120 is administered at 250 mg every other day on days 1, 3, 5, 7, 9, 11, and 13 of 21-day treatment cycles or at an adjusted dose, in combined with ruxolitinib administered orally twice daily following the dosing instructions in current prescribing information, to participants with intermediate or high risk, primary or secondary MF experiencing suboptimal response to JAK inhibitor.

Primary Outcome Measure

To evaluate the number of participants with a response (anti-cancer activity) to RVU120 when administered as a single agent or in combination with ruxolitinib [ Time Frame: 12 months ]

Central Contacts

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