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

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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