drugset
drugset / Trial / NCT04241549

A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment

NCT04241549 ↗

Phase 1 Completed 6 enrolled OncoVerity, Inc. Janssen Pharmaceutical K.K. · collabargenx · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are not candidates for intensive treatment.

Timeline

Start
2020-03-25
Primary completion
2021-07-19
Completion
2021-07-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Cusatuzumab Monoclonal antibody 20 mg/kg Intravenous
Background Azacitidine Other / unclassified 75 mg/m2 Subcutaneous

Indications

acute myeloid leukemia