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Small Molecule Inhibitor

A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies

Phase 1
Waitlist Available
Research Sponsored by Prelude Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through approximately 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called PRT543 in people with advanced cancers. The goal is to find the best way to use PRT543 safely in future treatments.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Leukemia
  • Adenoid Cystic Carcinoma
  • B-Cell Lymphoma
  • Myelodysplastic Syndrome
  • Mantle Cell Lymphoma
  • Myelofibrosis
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through approximately 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To describe dose limiting toxicities (DLT) of PRT543
To determine the maximally tolerated dose (MTD)
To determine the recommended phase 2 dose (RP2D) and schedule of PRT543
Secondary study objectives
To describe the adverse event profile and tolerability of PRT543
To determine the maximum observed plasma concentration (Cmax) of PRT543
To determine the time to reach maximum observed plasma concentration (Tmax) of PRT543
Other study objectives
To determine the area under the plasma concentration versus time curve (AUC) of PRT543
To determine the terminal elimination half-life (t1/2) of PRT543.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PRT543Experimental Treatment1 Intervention
PRT543 will be administered orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRT543
2019
Completed Phase 1
~240

Find a Location

Who is running the clinical trial?

Prelude TherapeuticsLead Sponsor
10 Previous Clinical Trials
825 Total Patients Enrolled
~34 spots leftby Dec 2025
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