drugset / Trial / NCT05038800

A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)

NCT05038800

Phase 1 Terminated 13 enrolled Merck Sharp & Dohme LLC
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and recommended Phase 2 dose (RP2D) of MK-0482. There are 2 parts of this study. Part 1 is a dose escalation which will follow an accelerated titration design (ATD) for participants with relapsed/refractory (R/R) AML or CMML. Part 2 is a dose expansion for participants with R/R AML.

Timeline

Start
2021-09-26
Primary completion
2023-12-11
Completion
2023-12-11

Drugs

EvaluationDrugModalityDoseRoute
Subject MK-0482 Unknown 7.5 mg Intravenous
Subject MK-0482 Unknown 25 mg Intravenous
Subject MK-0482 Unknown 75 mg Intravenous
Subject MK-0482 Unknown 225 mg Intravenous
Subject MK-0482 Unknown 750 mg Intravenous