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Small Molecule Inhibitor

PRT543 for Chronic Myelomonocytic Leukemia

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
Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All malignancies must be refractory to established therapies
Biomarker-selected solid tumors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through approximately 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and what the best dose is.

Eligible Conditions
  • Solid Tumors
  • Chronic Myelomonocytic Leukemia
  • Acute Myeloid Leukemia
  • Adenoid Cystic Carcinoma
  • Myelofibrosis
  • Mantle Cell Lymphoma
  • Myelodysplasia
  • B-Cell Lymphoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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.

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
8 Previous Clinical Trials
423 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~38 spots leftby Mar 2025