Therapeutic RSK1 Targeting in Myelofibrosis

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07379125
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myelofibrosis

Eligibility Criteria

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

Interventions

  • PMD-026 — DRUG
    PMD-026 is an oral drug which will be taken every 12 hours on an outpatient basis at the assigned dose every day of each 28-day cycle. Provided by Phoenix Molecular Designs.

Study Details

This is a phase Ib study evaluating PMD-026, an oral inhibitor of ribosomal protein S6 kinase A1 (RSK1), in participants with myelofibrosis (MF).The dose escalation portion utilizes a standard 3+3 design to evaluate two dose levels with an additional dose de-escalation portion to identify the recommended phase II dose (RP2D); subsequently, an additional 6 patients will be enrolled in the dose expansion portion evaluating the efficacy of PMD-026.

Key Dates

First listed
Jan 30, 2026
Start date
May 20, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Dose Level -1: PMD-026
    PMD-026 will be taken by mouth twice daily at the assigned dose every day of each 28-day cycle.
  • Experimental: Dose Escalation Dose Level 1 (Starting Dose): PMD-026
    PMD-026 will be taken by mouth twice daily at the assigned dose every day of each 28-day cycle.
  • Experimental: Dose Escalation Dose Level 2: PMD-026
    PMD-026 will be taken by mouth twice daily at the assigned dose every day of each 28-day cycle.
  • Experimental: Dose Expansion - Recommended Phase II Dose (RP2D): PMD-026
    PMD-026 will be taken by mouth twice daily at the recommended phase II dose every day of each 28-day cycle.

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: From cycle 1 day 1 through 28 days after last dose (estimated to be 1 year and 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Amy W Zhou, M.D.
[email protected]
314-362-8814
Amy W Zhou, M.D. (PRINCIPAL_INVESTIGATOR)
Liang Huang, M.D. (SUB_INVESTIGATOR)
Feng Gao, Ph.D. (SUB_INVESTIGATOR)

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By research site
Washington University School of Medicine· St Louis, MO

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