A Study to Evaluate Escalating Doses of ASP1235 (AGS62P1) Given as Monotherapy in Subjects With Acute Myeloid Leukemia (AML)

Phase 1 Terminated 43 enrolled Astellas Pharma Global Development, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of ASP1235 (AGS62P1) given at three dosing schedules (Schedule A, every three weeks \[Q3W\] or Schedule B, every other week of a 4 week cycle \[Q2W\] or Schedule C once a week for 3 weeks of a 4 week cycle) in subjects with acute myeloid leukemia (AML) and determine the maximum tolerated dose (MTD). In addition, this study will assess the pharmacokinetics (PK), the immunogenicity and the anti-leukemic activity of ASP1235 (AGS62P1).

Timeline

Start: 2016-11-10
Primary completion: 2020-09-03
Completion: 2020-09-03

Outcome

Outcome not reported

Stopped: “Study was terminated due to lack of efficacy.”

Publications

Al Malki MM, Minden MD, Rich ES, Hill JE, Gill SC, Fan A, Fredericks CE, Fathi AT, Abdul-Hay M. Safety, tolerability, and pharmacokinetics of ASP1235 in relapsed or refractory acute myeloid leukemia: A phase 1 study. Leuk Res. 2025 May;152:107690. doi: 10.1016/j.leukres.2025.107690. Epub 2025 Apr 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AGS62P1	Unknown	—	Intravenous