A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Start Date
4/29/2026
Completion Date
4/1/2028
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).
Detailed Description
This first-in-human, open-label, multi-center Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in participants with high-risk polycythemia vera (PV) and myelofibrosis (MF). Eligible MF populations include participants with intermediate-1, intermediate-2, or high-risk primary MF, as well as post-polycythemia vera MF or post-essential thrombocythemia MF, with evidence of disease burden based on splenomegaly. The study is conducted in two parts: Part 1 (dose escalation) evaluates escalating oral doses of PRT12396 to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]). Part 2 (dose expansion) enrolls additional participants at selected dose level(s) to further characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396 in the PV and MF populations. Approximately up to 100 participants are planned for enrollment across both parts of the study.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
PRT12396
Conditions
Locations
Colorado Blood Cancer Institute
Denver, Colorado 80218
United States
BRCR Global - Coral Springs
Coral Springs, Florida 33065
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
START Midwest, LLC
Grand Rapids, Michigan 49546
United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office
Philadelphia, Pennsylvania 19107
United States
Tennessee Oncology, PLLC - Investigational Drug Services
Nashville, Tennessee 37203
United States
Tristar BMT
Nashville, Tennessee 37203
United States
The University of Texas, MD Anderson Cancer Center
Houston, Texas 77030
United States