Study of AMV564 in Patients With AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03144245
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : December 4, 2018
Information provided by (Responsible Party):
Amphivena Therapeutics, Inc.

April 25, 2017
May 8, 2017
December 4, 2018
March 20, 2017
February 20, 2020   (Final data collection date for primary outcome measure)
  • Dose escalation + expansion stage: incidence of all adverse events and serious adverse events (safety and tolerability) [ Time Frame: 36 months ]
    Number of participants with adverse events as a measure of safety and tolerability.
  • Expansion stage: Efficacy - Remission Rate [ Time Frame: 36 months ]
    Proportion of participants who achieve complete remission, complete remission with incomplete recovery or partial remission
Same as current
Complete list of historical versions of study NCT03144245 on Archive Site
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Study of AMV564 in Patients With AML
A Phase 1, First in Human, Open Label, Dose Escalation Study of AMV564, a CD33 x CD3 Tandem Diabody in Patients With Relapsed or Refractory Acute Myeloid Leukemia
This is a first in human, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of AMV564.
This study is a first in human, Phase 1, open label, multicenter, dose escalation study of AMV564 in patients with relapsed or refractory AML. Patients must have documented diagnosis of AML according to World Health Organization (WHO) criteria. After providing signed informed consent, patients will be screened for entry into the study. The study will be conducted in 2 stages. In a dose escalation stage, approximately 32 patients will be enrolled. Escalation cohorts of 3 to 6 patients will receive repeat doses of AMV564 to determine the MTD and RP2D. AMV564 will be administered daily for 14 days. In a second expansion phase, a total of 18 patients will receive AMV564 at the established RP2D.
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
Biological: AMV564
AMV564 for administration via continuous intravenous daily infusion.
Experimental: AMV564
Continuous infusion of AMV564 at increasing dose levels
Intervention: Biological: AMV564
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 20, 2020
February 20, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥ 18 years of age at the time of signing informed consent
  • Diagnosis of AML according to the World Health Organization (WHO) 2008 criteria
  • Relapsed or refractory disease meeting the following criteria:

    1. Primary refractory, ie, refractory to induction with a standard intensive anthracycline/cytarabine-based regimen or a hypomethylating agent (e.g. decitabine or azacitidine) for patients ineligible for anthracycline-based therapy;
    2. First untreated relapse after a first complete remission (CR) lasting less than 12 months, or first relapse refractory to salvage regardless of length of first CR; or
    3. Second or later relapse. Relapse is defined as the reappearance of leukemic blasts in the peripheral blood or ≥ 5% leukemic blasts in the bone marrow after prior achievement of a CR or CRi.
  • Blasts at least 5% in bone marrow
  • Peripheral white blood cell (WBC) count: no upper limit at Screening, but must be < 10 x 109/L on Day 1 prior to treatment; patients with excessive blasts may be treated with hydroxyurea to bring counts down.
  • Chemistry laboratory parameters within the following range:

    1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x the upper limit of normal (ULN)
    2. Total bilirubin ≤ 1.5x the ULN; patients with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits.
    3. Creatinine clearance > 50 mL/min (measured or calculated by Cockcroft-Gault method)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Patients with ECOG score of 2 may be included, after discussion with the Sponsor Medical Monitor, if score is influenced by symptoms attributable to underlying AML disease.
  • Able to read, understand and provide written informed consent

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study.

  • History of, or known, central nervous system (CNS) disease involvement, or prior history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Grade ≥ 3 drug-related CNS toxicity
  • Prior allogeneic transplant is excluded during Dose Escalation Stage;
  • Prior solid organ transplantation
  • Treatment with anti-thymocyte globulin (ATG) within 14 days prior to start date
  • Treatment with any local or systemic antineoplastic therapy or radiation within 14 days prior to the initiation of AMV564 administration (hydroxyurea is exempted if used to reduce total WBC counts)
  • Clinically significant cardiac disease,
  • Pulmonary, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements
  • Evidence of active, uncontrolled, viral, bacterial, or systemic fungal infection. Prophylactic therapy according to institutional protocols is acceptable.
  • Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
  • Active hepatitis C virus (HCV) or hepatitis B virus (HBV).
  • Second primary malignancy that has not been in remission for greater than 3 years. Exceptions that do not require a 3-year remission include: non-melanoma skin cancer; cervical carcinoma in situ on biopsy or squamous intraepithelial lesion on Papanicolaou (PAP) smear; localized prostate cancer (Gleason score < 6); or resected melanoma in situ.
  • Any serious underlying medical or psychiatric condition (e.g. alcohol or drug abuse), dementia or altered mental status or any issue that would impair the ability of the patient to understand informed consent or that in the opinion of the investigator would contraindicate the patient's participation in the study or confound the results of the study.
  • Ability to become pregnant. However, female patients who have a negative serum or urine pregnancy test before enrollment and agree to use two highly effective forms of contraception (oral, injected or implanted hormonal contraception and condom; intrauterine device and condom; diaphragm with spermicidal gel and condom) during the trial and for 90 days afterward (90 days after the end of AMV564 treatment) are considered eligible.
  • Male patients with partners of childbearing potential.
  • Pregnant or breastfeeding women
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Eric J. Feldman, M.D. 206-773-3568
United States
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Amphivena Therapeutics, Inc.
Amphivena Therapeutics, Inc.
Not Provided
Not Provided
Amphivena Therapeutics, Inc.
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP