Spots Global Cancer Trial Database for Study of AMV564 in Patients With AML
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Trial Identification
Brief Title: Study of AMV564 in Patients With AML
Official Title: 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
Study ID: NCT03144245
Conditions
Study Description
Brief Summary: This is a first in human, non randomized, open-label, dose escalation study to investigate the safety, tolerability and preliminary efficacy of AMV564.
Detailed Description: This study is a first in human, Phase 1, open label, multicenter, dose escalation study with expansion at the RP2D to evaluate the safety, tolerability and preliminary antileukemic activity of AMV564 in patients with relapsed or refractory acute myeloid leukemia (AML). AMV564 will be given on Days 1-14 of a 4-week cycle, or Days 1-28 of a 6-week cycle,via CIV or subcutaneous administration for 1 or more treatment cycles as monotherapy or in combination with pembrolizumab.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Francisco, San Francisco, California, United States
Northwestern, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
New York Medical College, Hawthorne, New York, United States
Weill Cornell Medical College, The New York Presbyterian Hospital, New York, New York, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center, The University of Texas, Houston, Texas, United States
Fred Hutchinson Cancer Research, Seattle, Washington, United States
Contact Details
Name: Patrick Chun, MD
Affiliation: Amphivena Therapeutics, Inc.
Role: STUDY_DIRECTOR
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