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

Amphivena Therapeutics, Inc.10 sites in 1 country53 target enrollmentMarch 20, 2017

ConditionsAcute Myeloid Leukemia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute Myeloid Leukemia
Sponsor: Amphivena Therapeutics, Inc.
Enrollment: 53
Locations: 10
Primary Endpoint: Dose escalation + expansion stage: incidence of all adverse events and serious adverse events (safety and tolerability)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 20, 2017

End Date

November 5, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Amphivena Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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:
•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
•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
•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.

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)