drugset
drugset / Trial / NCT04086264

IMGN632 as Monotherapy or With Venetoclax and/or Azacitidine for Participants With CD123-Positive Acute Myeloid Leukemia

NCT04086264 ↗

Phase 1/2 Active not recruiting 218 enrolled AbbVie
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, Phase 1b/2 study to determine the safety and tolerability of IMGN632 and assess the antileukemia activity of IMGN632 when administered in combination with azacitidine and/or venetoclax in participants with relapsed and frontline CD123-positive AML.

Timeline

Start
2019-11-06
Primary completion
2027-02
Completion
2027-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 35 mg/m2 Subcutaneous
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Pivekimab Sunirine Unknown 0.015 mg/kg Intravenous
Subject Pivekimab Sunirine Unknown 0.045 mg/kg Intravenous
Subject Pivekimab Sunirine Unknown 0.09 mg/kg Intravenous
Subject Venetoclax Small molecule 400 mg Oral

Indications

acute myeloid leukemia