PRT12396 for Polycythemia Vera and Myelofibrosis

Overseen By Study Contact (Please Do Not Disclose Personal Information)

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Prelude Therapeutics

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Other malignancy, Anemia, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

Inclusion Criteria

Estimate life expectancy of ≥12 weeks per investigator assessment

I am willing and able to follow all study visits, treatments, and requirements.

Negative serum or urine pregnancy test and agree to use contraception or maintain true abstinence

Exclusion Criteria

I do not have any serious or uncontrolled health problems that could affect my safety in the study.

I have not had another cancer in the past 3 years, unless it was cured and unlikely to return.

I have anemia caused by a nutritional deficiency or a blood disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive 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])

4 weeks

Weekly visits for dose adjustments and monitoring

Dose Expansion

Additional participants are enrolled at selected dose level(s) to further characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of PRT12396

Up to 2 years

Monthly visits for monitoring and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PRT12396

How Is the Trial Designed?

Group I: PRT12396: PV Experimental Treatment 1 Intervention

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)

Group II: PRT12396: MF Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Prelude Therapeutics

Lead Sponsor

Trials

11

Recruited

910+