Clinical Trials /

A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes

NCT03516591

Description:

An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes

Related Conditions:
  • Myelodysplastic Syndromes
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes
  • Official Title: A Phase 1, Multicenter, Open Label Study of AMV564, a Bispecific CD33/CD3 T-cell Engager, in Patients With Intermediate or High-Risk Myelodysplastic Syndromes

Clinical Trial IDs

  • ORG STUDY ID: AMV564-201
  • NCT ID: NCT03516591

Conditions

  • Myelodysplastic Syndrome (MDS)

Interventions

DrugSynonymsArms
AMV564 14-Day CIVDose Escalation (3+3 design)

Purpose

An open label, Phase 1, study of AMV564 as monotherapy to assess the safety and efficacy in patients with Myelodysplastic Syndromes

Detailed Description

      A dose-escalation with expansion study of AMV564 (T cell engager) as monotherapy in patients
      with intermediate-2 or high-risk Myelodysplastic Syndromes
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation (3+3 design)ExperimentalA 3 + 3 design, with dose-escalation of AMV564, up to a Maximum Tolerated Dose (MTD) level. AMV564 will be tested as a 14-Day CIV regimen (14-Day Continuous Intravenous Infusion Regimen).
  • AMV564 14-Day CIV
Dose ExpansionExperimentalFollowing determination of the MTD of AMV564, the study will expand at the MTD or a dose level lower than the MTD to obtain initial estimates of response rates and additional information on safety.
  • AMV564 14-Day CIV

Eligibility Criteria

        Inclusion Criteria:

          -  ≥ 18 years of age

          -  Diagnosis of MDS according to WHO 2016 criteria

          -  ECOG performance status of 0 or 1

          -  Intermediate-2 or high-risk disease per IPSS

          -  Fewer than 20% blasts in the bone marrow or peripheral blood

          -  Disease that is refractory to or relapsed from either a hypomethylating agent (e.g.
             decitabine or azacitidine) or a standard AML-type intensive regimen

          -  Adequate organ function

          -  Prior allogeneic transplant performed ≥ 3 months prior to first dose of AMV564 is
             allowed provided there is no evidence of active graft-versus-host disease (GVHD) and
             the patient has been off immunosuppressive therapy for ≥ 4 weeks.

        Exclusion Criteria:

          -  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 if performed < 3 months prior to first dose of AMV564, if
             patient has active GVHD, or if patient has not been off immunosuppressive

          -  Prior treatment with a therapeutic agent targeting CD33 (e.g. gemtuzumab ozogamicin,
             SGN-CD33A or AMG 330).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicity (Dose Escalation)
Time Frame:DLTs will be evaluated through 28 days for the 14-Day Continuous Intravenous Infusion Infusion regimen, and 35 days for the Intermittent Intravenous Dosing regimen
Safety Issue:
Description:Dose limiting toxicity to be measured by AEs and SAEs by dose level

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Amphivena Therapeutics, Inc.

Last Updated

May 21, 2020