Actively Recruiting
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Led by Prelude Therapeutics · Updated on 2026-05-14
100
Participants Needed
2
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or more 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)
You will not qualify if you...
- 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 greater than Grade 1 from prior anticancer therapy, except for alopecia or peripheral neuropathy Grade 2 or less.
- 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.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
BRCR Global - Coral Springs
Coral Springs, Florida, United States, 33065
Actively Recruiting
2
START Midwest, LLC
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
Research Team
S
Study Contact (Please Do Not Disclose Personal Information)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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