A Phase I, Open-Label, Multi-Center, Safety and Efficacy Study of PRT12396 in Participants With Polycythemia Vera and Myelofibrosis
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Study 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).
To study the effect of PRT12396, a JAK2V617F-selective JH2 inhibitor for the treatment of Myeloproliferative Neoplasms
- * 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 0-2
- * 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)
- 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.
Clinical Study Information for Healthcare Providers
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