Clinical Trials /

Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia

NCT02674763

Description:

This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive disease.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
  • Official Title: A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: IMGN779 0601
  • NCT ID: NCT02674763

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
IMGN779Dose Escalation Schedule A

Purpose

This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive disease.

Detailed Description

      In the Dose Escalation Phase, patients will be assigned to one of three schedules. The MTD
      for all schedules will be determined from the assessment of Dose Limiting Toxicities (DLTs).
      The Dose Expansion Phase will consist of one cohort based on patients response to prior
      therapy according to the MTD selected.
    

Trial Arms

NameTypeDescriptionInterventions
Dose Escalation Schedule AExperimentalIMGN779 administered on days 1 and 15 of a 28-day cycle
  • IMGN779
Dose Escalation Schedule BExperimentalIMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle
  • IMGN779
Dose Escalation Schedule CExperimentalIMGN779 administered on days 1 and 8 of a 21-day cycle
  • IMGN779
Dose Expansion CohortExperimentalPatients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.
  • IMGN779

Eligibility Criteria

        Inclusion Criteria:

          -  Dose Escalation: Patients with relapsed or refractory AML

          -  Dose Expansion: Patients with relapsed AML or patients who refuse, or are not suitable
             candidates for induction therapy

        Exclusion Criteria:

          -  Dose Escalation: Acute Promyelocytic Leukemia

          -  Any concurrent anti-cancer therapy including chemotherapy, immunotherapy,
             radiotherapy, biologic or any investigational agents (with the exception of
             hydroxyurea or leukapheresis for control of hyperleukocytosis) within 14 days or five
             half-lives of drugs, whichever is shorter, prior to Cycle 1 Day 1

          -  AML patients with known, active leptomeningeal/central nervous system (CNS)
             involvement

          -  Prior treatment with IMGN779

          -  Women who are pregnant or breast feeding
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum Tolerated Dose (MTD) of IMGN779
Time Frame:28 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Treatment emergent adverse events
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:PK parameters: maximum plasma concentration (Cmax) of IMGN779
Time Frame:up to 12 months
Safety Issue:
Description:
Measure:PK parameters: area under the time-concentration curve (AUC) of IMGN779
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:PK parameters: terminal half-life (t½) of IMGN779
Time Frame:Up to 12 months
Safety Issue:
Description:
Measure:Immunogenicity: Presence of Antibody-Drug Antibody (ADA)
Time Frame:Up to 12 months
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:ImmunoGen, Inc.

Trial Keywords

  • Acute Myeloid Leukemia
  • AML
  • IMGN779
  • ImmunoGen
  • Phase 1
  • Relapsed
  • Refractory
  • CD33
  • Dose Escalation
  • Dose Expansion

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