Clinical Trials /

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

NCT02520427

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study of AMG 330 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
  • Official Title: A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: 20120252
  • SECONDARY ID: 2014-004462-20
  • NCT ID: NCT02520427

Conditions

  • Relapsed/Refractory AML

Interventions

DrugSynonymsArms
AMG 330AMG 330

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
AMG 330ExperimentalComparison of different dosages of drug
  • AMG 330

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Subject incidence of adverse events as a Measure of Safety
Time Frame:36 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of anti-AMG 330 antibody formation
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: Response rate
Time Frame:36 months
Safety Issue:
Description:Response is defined as CR, CRi, morphologic leukemia-free state [per modified IWG criteria] or CRh*
Measure:Efficacy parameter: duration of response
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: time to progression
Time Frame:36 months
Safety Issue:
Description:
Measure:Efficacy parameter: time to response
Time Frame:36 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Half-life of AMG330
Time Frame:32 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Steady state concentration of AMG330
Time Frame:32 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Volume of distribution of AMG330
Time Frame:32 months
Safety Issue:
Description:
Measure:Pharmacokinetic parameter: Clearance of AMG330
Time Frame:32 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Trial Keywords

  • Amgen
  • Phase 1
  • Clinical Trial
  • Oncology/Hematology
  • Relapsed/Refractory AML
  • Immunotherapy

Last Updated

November 21, 2019