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A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Sponsor: Prelude Therapeutics Incorporated
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).
Official title: A Phase 1, Open-Label, Multi-Center, Safety and Efficacy Study of PRT12396 in Participants With Polycythemia Vera and Myelofibrosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-04-29
Completion Date
2028-04
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
PRT12396
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.
Locations (18)
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