RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Prelude Therapeutics Incorporated • ClinicalTrials.gov ID: NCT07469891

Registry updated: 2026-10-01

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Description

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).

Interventions

PRT12396 (Drug)
PRT12396 is an investigational oral capsule administered twice daily at the assigned dose level or RDE. Capsules are swallowed whole with water and may be taken one hour before or two hours after meals.

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 * Documented presence of a JAK2 V617 mutation * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Estimate life expectancy of ≥12 weeks per investigator assessment. * Negative serum or urine pregnancy test and agree to use contraception or maintain true abstinence. * Adequate organ function and bone marrow reserves (hematology, renal, and hepatic) Exclusion Criteria: * History of another malignancy within 3 years prior to enrollment, except for malignancy considered cured with low risk of recurrence. * Clinically significant anemia due to nutritional deficiency or hemolytic disorders. * Active or uncontrolled infection requiring systemic therapy or hospitalization. * Any other medical or psychiatric conditions that, in the Investigator's judgment, would increase risk or interfere with study participation or interpretation of results. * Clinically significant or uncontrolled medical conditions, including active infection or cardiovascular disease, that would increase risk or interfere with study participation. * Unresolved toxicity Grade \>1 from prior anticancer therapy, except for alopecia or peripheral neuropathy Grade ≤2. * Pregnancy or breastfeeding * Known sensitivity or contraindication to any component of study, or the excipients of study treatment. * Prior systemic therapy for PV or MF, prior or planned allogeneic hematopoietic stem-cell transplantation, recent major surgery, prior splenectomy or prior splenic irradiation, or use of hematopoietic growth factors within protocol-defined washout periods. * Use of strong or moderate cytochrome P450 (CYP) 3A4 inhibitor or inducer, sensitive CYP3A substrates with narrow therapeutic range, or acid-reducing agents that cannot be discontinued prior to study treatment. * Participation in another interventional clinical study.

Conditions

Polycythemia Vera (PV) Myelofibrosis (MF) Myeloproliferative Neoplasms (MPNs) Post-Polycythemia Vera Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis Primary Myelofibrosis (PMF)

Locations

UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
Colorado Blood Cancer Institute — Denver, Colorado, United States
BRCR Global - Coral Springs — Coral Springs, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
START Midwest, LLC — Grand Rapids, Michigan, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office — Philadelphia, Pennsylvania, United States
Tennessee Oncology, PLLC - Investigational Drug Services — Nashville, Tennessee, United States
Tristar BMT — Nashville, Tennessee, United States
The University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
Royal Adelaide Hospital — Adelaide, South Australia, Australia
Monash Health, Monash Medical Centre — Clayton, Victoria, Australia
One Clinical Research — Nedlands, Western Australia, Australia
Saint-Louis Hospital — Paris, France
Oncopole Claudius Regaud — Toulouse, France
Hospital Clinic de Barcelona — Barcelona, Spain
Hospital Universitario Ramon y Cajal — Madrid, Spain
Hospital Universitario 12 de Octubre — Madrid, Spain
Hospital Clínico Universitario de Valencia — Valencia, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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