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

Acute Myeloid Leukemia Clinical Trial

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 Details — Status: Completed

Administrative data

• NCT number: NCT02674763
• Other study ID #: IMGN779 0601
• Status: Completed
• Phase: Phase 1
• Start date: March 2016
• Est. completion date: July 2019

Study information

• Verified date: September 2019
• Source: ImmunoGen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• IMGN779

Locations

Country	Name	City	State
United States	New Mexico Cancer Care Alliance	Albuquerque	New Mexico
United States	Comprehensive Cancer Center (UAB CCC)	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Baylor Scott & White University Medical Center	Dallas	Texas
United States	The University of Texas, MD Anderson Cancer Center	Houston	Texas
United States	Knight Cancer Institute - OSHU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
ImmunoGen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) of IMGN779		28 days
Secondary	Treatment emergent adverse events		Up to 12 months
Secondary	Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])		Up to 12 months
Secondary	PK parameters: maximum plasma concentration (Cmax) of IMGN779		up to 12 months
Secondary	PK parameters: area under the time-concentration curve (AUC) of IMGN779		Up to 12 months
Secondary	PK parameters: terminal half-life (t½) of IMGN779		Up to 12 months
Secondary	Immunogenicity: Presence of Antibody-Drug Antibody (ADA)		Up to 12 months