drugset / Trial / NCT07469891

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

NCT07469891 ↗

Phase 1 Recruiting 100 enrolled Prelude Therapeutics
Non-randomizedSequentialOpen-labelTreatment

Summary

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 by a dose-expansion phase to further evaluate selected dose level(s).

Timeline

Start
2026-04-29
Primary completion
2028-04
Completion
2028-04

Drugs

EvaluationDrugModalityDoseRoute
Subject PRT12396 Unknown — Oral