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

NCT ID: NCT03224819

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-07
• Study Completion Date: 2020-12-28

Brief Summary

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]).

Detailed Description

This is a first-in-human, open-label, phase 1, sequential dose escalation study. Emerfetamab will be evaluated as a short term intravenous (IV) infusion in adults with relapsed/refractory AML The study will consist of a dose escalation phase and a dose expansion phase. The study was terminated prior to the start of the expansion phase.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation

The dose-escalation cohorts to estimate the MTD will use 2 schedules of emerfetamab administration: Schedule A (Day 1/Day 5 dosing in 14-day cycles) and Schedule B (once daily dosing for cycle 1 followed by twice weekly dosing in following cycles).

For Schedule A the starting dose for the first cohort will be 0.05 μg emerfetamab administered as short term IV infusions on day 1 and day 5. The doses administered for the following cohorts will be recommended by the Dose Level Review Team (DLRT).

For Schedule B the starting dose will be 72 μg emerfetamab administered as short-term IV infusions daily (QD) during the 14-day cycle 1 after the 72 μg target dose is found to be relatively safe and tolerable by the DLRT for Schedule A.

Group Type: EXPERIMENTAL

Emerfetamab

Intervention Type: DRUG

Administered by intravenous (IV) infusion.

Expansion Phase

For each schedule, upon completion of the dose escalation cohorts, additional participants may be enrolled to receive emerfetamab at a dose at or below the MTD estimated in the dose escalation cohorts.

Group Type: EXPERIMENTAL

Emerfetamab

Intervention Type: DRUG

Administered by intravenous (IV) infusion.

Interventions

Emerfetamab

Administered by intravenous (IV) infusion.

Intervention Type: DRUG

Other Intervention Names

AMG 673

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

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

München, , Germany

Countries

United States; Australia; Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2017-002980-16

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20160377

Identifier Type: -

Identifier Source: org_study_id