RecruitingPhase 1NCT06613217

Study of Oral PCLX-001 in R/R Acute Myeloid Leukemia

A Phase 1 Study of Oral PCLX-001 in Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML)


Sponsor

Pacylex Pharmaceuticals

Enrollment

35 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a dose-finding study of oral zelenirstat (PCLX-001) in patients with R/R AML. There are two parts to the study: Dose Escalation and Dose Expansion.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an oral drug called PCLX-001 in people with relapsed or refractory acute myeloid leukemia (AML) — meaning their leukemia has come back or stopped responding to prior treatments. The drug works by blocking a specific enzyme that leukemia cells depend on to survive. **You may be eligible if...** - You are an adult (18 or older) - You have been diagnosed with AML that has come back or has not responded to prior treatment - You have had at least one prior course of AML treatment - You are in adequate physical health with acceptable blood counts and organ function **You may NOT be eligible if...** - You have active, serious infections - You have certain heart rhythm problems (like prolonged QTc interval) - You have significant liver or kidney impairment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGzelenirstat

Zelenirstat will be administered orally, once daily, on 28-day cycles, at the same time each day.


Locations(1)

MD Anderson Cancer Centre

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06613217


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