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Study of AMV564 in Patients With AML | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT03144245•Amphivena Therapeutics, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 non-intensive regimen (e.g., decitabine, azacytidine, low-dose cytarabine) for patients ineligible for an intensive anthracycline/cytarabine-based therapy
•2. First untreated relapse after a first CR lasting less than 12 months or first relapse refractory to salvage therapy 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.
•OR Patients with newly diagnosed therapy-related AML, AML progressed from antecedent MDS or CMML treated with hypomethylating agents, or de novo AML with MDS-related cytogenetic abnormalities (per 2008 WHO criteria) and who are not candidates for (or decline) intensive remission induction therapy
•No more than 3 prior induction/salvage regimens to treat active disease, and no more than 1 prior stem cell transplant. Any number of continuous cycles of therapy with an individual hypomethylating agent count as one induction or salvage regimen.
•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.
+7 more criteria

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 (dose escalation only)
•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)
+8 more criteria

Locations (10)

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

St 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

Key Dates

Start Date

March 20, 2017

Primary Completion Date

July 21, 2020

Completion Date

November 5, 2020

Last Updated

October 12, 2021

Enrollment

ACTUAL participants

Conditions

Acute Myeloid Leukemia

Interventions

AMV564

BIOLOGICAL

AMV564 in combination with pembrolizumab

COMBINATION_PRODUCT

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITINGPHASE2

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

NCT06220162

Acute Myeloid Leukemia

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RECRUITINGPHASE1/PHASE2

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of AMV564 in Patients With AML

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes

A Study of CBX-250 in Participants With Relapsed or Refractory Myeloid Leukemias