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OncoMatch/Clinical Trials/NCT07469891

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

Is NCT07469891 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PRT12396 for polycythemia vera (pv).

Phase 1RecruitingPrelude TherapeuticsNCT07469891Data as of May 2026

Treatment: PRT12396This 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).

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Extracted eligibility criteria

Cancer type

Myeloproliferative Neoplasm

Biomarker criteria

Required: JAK2 v617 mutation

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)

Cannot have received: systemic therapy for PV or MF

Prior systemic therapy for PV or MF

Cannot have received: allogeneic hematopoietic stem-cell transplantation

Exception: prior or planned

prior or planned allogeneic hematopoietic stem-cell transplantation

Cannot have received: splenectomy

prior splenectomy

Cannot have received: splenic irradiation

prior splenic irradiation

Cannot have received: hematopoietic growth factors

Exception: within protocol-defined washout periods

use of hematopoietic growth factors within protocol-defined washout periods

Lab requirements

Blood counts

adequate bone marrow reserves (hematology)

Kidney function

adequate renal function

Liver function

adequate hepatic function

Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • START Midwest, LLC · Grand Rapids, Michigan

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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