A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms

Recruiting Phase 1 Interventional Study
Polycythemia Vera (PV) Myelofibrosis (MF) Myeloproliferative Neoplasms (MPNs) Post-Polycythemia Vera Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis Primary Myelofibrosis (PMF)
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Prelude Therapeutics · Industry
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About This Trial
This is a first-in-human, open-label, multi-center Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in participants with high-risk polycythemia vera (PV) and myelofibrosis (MF), and to determine the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]). The study consists of a dose-escalation phase followed …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures. * Confirmed diagnosis of PV or MF according to WHO 2016 or revised ICC/WHO 2022 criteria * Docum…
Contacts

Study Contact (Please Do Not Disclose Personal Information)

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clinicaltrials@preludetx.com

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