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.
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of participants with adverse events
Timeframe: From cycle 1 day 1 through 28 days after last dose (estimated to be 1 year and 28 days)
Number of participants with dose limiting toxicities (DLTs) based on occurrence of serious treatment-emergent adverse events (Dose Escalation only)
Timeframe: During cycle 1 of treatment (each cycle is 28 days)
Recommended phase II dose (RP2D) (Dose Escalation only)
Timeframe: Completion of cycle 1 (each cycle is 28 days) of all dose-escalation patients (estimated to be 1 year and 28 days)
Changes in spleen size (Dose Expansion and RP2D Cohort in Dose Escalation)
Timeframe: Baseline and after 24 weeks of treatment (estimated to be 24 weeks)
Changes in Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 Total Symptom Score (Dose Expansion and PR2D Cohort in Dose Escalation)
Timeframe: Baseline and after 24 weeks of treatment (estimated to be 24 weeks)
Bone marrow histopathologic response (Dose Expansion and RP2D Cohort in Dose Escalation)
Timeframe: Baseline and after 24 weeks of treatment (estimated to be 24 weeks)
Overall response rate (ORR) (Dose Expansion and RP2D Cohort in Dose Escalation)
Timeframe: Baseline and after 24 weeks of treatment (estimated to be 24 weeks)