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PRT12396

Phase 1

Polycythemia Vera (PV) | Small molecule | Oncology |Prelude Therapeutics Incorporated|Last Updated: Jun 9, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical trial landscape

PRT12396 · 1 trial · 6 indications

Phase 1 1
NCT07469891A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative NeoplasmsPolycythemia Vera (PV)
RECRUITING100 Analytics
PHASE1RECRUITING
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Polycythemia Vera (PV)
NCT07469891100
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Study Endpoints
Primary Endpoints
Dose limiting toxicity (DLT) of PRT12396
Through cycle 1 (4 weeks)

Incidence of dose limiting toxicities, defined according to protocol-specified criteria

Incidence and severity of Adverse events
Through study completion, an average of 2 years

Incidence and severity of treatment-emergent adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0

Adverse Events Leading to Dose Modifications or Discontinuation
Through study completion, an average of 2 years

Incidence of AEs leading to dose reductions, dose interruptions, treatment discontinuations, and clinically significant laboratory abnormalities

Maximum tolerated dose (MTD) and Recommended Dose(s) for Expansion (RDE[s]) of PRT12396
Through study completion, an average of 2 years

Determination of the maximum tolerated dose (MTD) and recommended dose(s) for expansion (RDE\[s\]) based on evaluation of DLTs, safety, and tolerability data

Secondary Endpoints
Hematologic Response Rate (PV)
Through study completion, an average of 2 years
Duration of Hematologic Response (PV)
Through study completion, an average of 2 years
Hematocrit Control Without Phlebotomy Requirements (PV)
Through study completion, an average of 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PRT12396: MFEXPERIMENTALParticipants 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)
PRT12396: PVEXPERIMENTALParticipants 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)
Interventions
NameTypeDescription
PRT12396DRUGPRT12396 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.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * 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 * Docum...

Countries:United States
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Competitive Landscape -Polycythemia Vera 11 trials (matched to "Polycythemia Vera (PV)")
CompanyTickerTrialsLead PhaseDrugs
Protagonist Therapeutics, Inc.PTGX2PHASE3Rusfertide
Merck & Co., Inc.MRK1PHASE3Bomedemstat
Disc Medicine, Inc.IRON1PHASE2DISC-3405
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
Novartis AG Sponsored ADRNVS1 - Undisclosed
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Recent Changes (Last 90 Days)
LOWJun 9, 2026NCT07469891lastUpdatePostDate: changed
LOWJun 9, 2026NCT07469891lastUpdatePostDate: changed
LOWJun 9, 2026NCT07469891lastUpdatePostDate: changed
LOWJun 9, 2026NCT07469891lastUpdatePostDate: changed
LOWMay 29, 2026NCT07469891lastUpdatePostDate: changed
LOWMay 29, 2026NCT07469891lastUpdatePostDate: changed
LOWMay 29, 2026NCT07469891lastUpdatePostDate: changed
LOWMay 26, 2026NCT07469891Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07469891studyFirstPostDate: changed