Skip to main content
OpenTrials
Completed

NCT Number: NCT02674763

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comprehensive Cancer Center (UAB CCC), Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMGN779

Drug

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of IMGN779

    Time frame: 28 days

Secondary outcomes

  1. Treatment emergent adverse events

    Time frame: Up to 12 months

  2. Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])

    Time frame: Up to 12 months

  3. PK parameters: maximum plasma concentration (Cmax) of IMGN779

    Time frame: up to 12 months

  4. PK parameters: area under the time-concentration curve (AUC) of IMGN779

    Time frame: Up to 12 months

  5. PK parameters: terminal half-life (t½) of IMGN779

    Time frame: Up to 12 months

  6. Immunogenicity: Presence of Antibody-Drug Antibody (ADA)

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

ImmunoGen, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2016
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.