drugset / Trial / NCT03541369

Safety, Tolerability, PK, PD, and Efficacy of AMG 427 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

NCT03541369 ↗

Phase 1 Terminated 64 enrolled Amgen
Non-randomizedSequentialOpen-labelTreatment

Summary

Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory (R/R) acute myeloid leukemia (AML). Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose \[RP2D\]).

Timeline

Start
2018-09-14
Primary completion
2023-02-21
Completion
2023-02-21

Outcome

Outcome not reported

Stopped (Business): “Premature discontinuation of study, a strategic decision.”

Drugs

EvaluationDrugModalityDoseRoute
Subject EMIRODATAMAB Monoclonal antibody — Intravenous