Study of Emerfetamab (AMG 673) in Adults With Relapsed/Refractory Acute Myeloid Leukemia (AML)

Stopped early · Early Phase 1

Conditions studied: Acute Myeloid Leukemia

In brief

The primary objectives of this study are to evaluate the safety and tolerability of emerfetamab in adults with relapsed/refractory acute myeloid leukemia (AML) and to estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose \[RP2D\]).

Key facts

Study ID: NCT03224819
Run by: Amgen
People needed: 46
Starts: 2017-09-07
Expected to finish: 2020-12-28
Last updated by the study team: 2023-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
Subjects ≥ 18 years of age at the time of signing consent.
AML as defined by the World Health Organisation (WHO) Classification persisting or recurring following 1 or more treatment courses except promyelocytic leukemia (APML).
More than 5% myeloblasts in bone marrow.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.

You may not qualify if…

Known hypersensitivity to immunoglobulins.
Autologous hematopoietic stem cell transplantation (HSCT) within 6 weeks prior to start of AMG 673 treatment.
Allogeneic HSCT within 3 months prior to start of AMG 673 treatment.
Non-manageable graft versus host disease.
Known positive test for human immunodeficiency virus (HIV).
Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 15 weeks after receiving the last dose of study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women). Males who are unwilling to abstain from sperm donation while on study through 5 half-lives after receiving the (last [multiple-dose studies]) dose of study drug.
Females who are lactating/breastfeeding or who plan to breastfeed while on study through 15 weeks after receiving the last dose of study drug.
Females with a positive pregnancy test
Females planning to become pregnant while on study through 15 weeks after receiving the last dose of study drug.

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
City of Hope National Medical Center — Duarte, California, United States
University of Texas MD Anderson Cancer Center — Houston, Texas, United States
University of Washington — Seattle, Washington, United States
The Alfred Hospital — Melbourne, Victoria, Australia
The Royal Melbourne Hospital — Parkville, Victoria, Australia
Klinikum der Ludwig Maximilians Univeritaet — MÃ¼nchen, Germany

Full record on ClinicalTrials.gov

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