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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Prelude Therapeutics
Study ID
NCT07469891
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Apr 29, 2026
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PRT12396: MF
    Participants with myelofibrosis receive PRT12396, an investigational oral capsule, administered twice daily. The study includes a dose-escalation followed by dose-expansion at the recommended dose for expansion (RDE)
  • Experimental: PRT12396: PV
    Participants with polycythemia vera receive PRT12396, an investigational oral capsule, administered twice daily. The study includes a dose-escalation followed by dose-expansion at the recommended dose for expansion (RDE)

Primary Outcome Measure

Dose limiting toxicity (DLT) of PRT12396 [ Time Frame: Through cycle 1 (4 weeks) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218-
BRCR Global - Coral SpringsCoral SpringsFlorida33065-
START Midwest, LLCGrand RapidsMichigan49546-
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials OfficePhiladelphiaPennsylvania19107-
Tristar BMTNashvilleTennessee37203-

Find similar trials in Denver, CO

By research site
Colorado Blood Cancer Institute· Denver, COBRCR Global - Coral Springs· Coral Springs, FLSTART Midwest, LLC· Grand Rapids, MIThomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office· Philadelphia, PATristar BMT· Nashville, TN

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