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A Phase 1 Study of AMG 330 in Subjects With Relapsed / Refractory Acute Myeloid Leukemia

Trial Status: Active

The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have relapsed / refractory Acute Myeloid Leukemia, and to determine the maximum tolerated dose and / or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Inclusion Criteria

  • Informed consent provided
  • 18 years or older
  • AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML). For Germany, additional requirements are outlined in a country specific protocol supplement.
  • More than 5% blasts in bone marrow
  • ECOG Performance Status of ≤ 2
  • Adequate renal and hepatic function

Exclusion Criteria

  • Active extramedullary AML in testes or central nervous system (CNS)
  • Known hypersensitivity to immunoglobulins or to any other component of the IP formulation
  • Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening
  • Autologous HSCT within six weeks prior to start of AMG 330 treatment
  • Allogeneic HSCT within three months prior to start of AMG 330 treatment
  • History or evidence of cardiovascular risk
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3 months Infection requiring intravenous antibiotics within 1 week of study enrollment (day 1)
  • Known positiv test for HIV
  • Positive for Hepatitis B
  • Positive for Hepatitis C or chronic Hepatitis C
  • Unresolved toxicities from prior antitumor therapy, defined as not having resolved to CTCAE, version 4.0 grade 1
  • Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent) within 14 days or 5 half-lives of day 1 (whichever is shorter). Exception: hydroxyurea to control peripheral blood leukemic cell counts is allowed until start of IP treatment.
  • Treatment with systemic immune modulators 2 weeks before enrollment (day 1)
  • All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 330 will be reviewed by the investigator and the Amgen medical monitor
  • Prior treatment with a chimeric antigen receptor T cell (CAR-T) infusion for the treatment of AML (CD33 or other target)
  • Major surgery within 28 days of study day 1 with the exception of biopsy and long line insertion
  • White blood cells (WBC) > 15,000 cells/mcL at screening
  • History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Men and women of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 1 week (women) or 12 weeks (men)
  • Women who are lactating/breastfeeding or who plan to breastfeed while on sudy through 1 week after receiving the last dose of study drug
  • Women with a positive pregnancy test
  • Women planning to become pregnant while on study through 1 week after receiving the last dose of study drug
  • Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Anthony S. Stein
Phone: 800-826-4673

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Contact: Roland Bruno Walter
Phone: 800-422-6237

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Amgen, Inc.

  • Primary ID 20120252
  • Secondary IDs NCI-2015-01427, 2014-004462-20
  • Clinicaltrials.gov ID NCT02520427