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

Phase 1

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: IMGN779

• Registration Number: NCT02674763
• Lead Sponsor: ImmunoGen, Inc.

Brief 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.

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.

Study Timeline

• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-04
• Study Start: 2016-03
• Primary Completion: 2019-06
• Study Completion: 2019-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose Escalation Schedule A	IMGN779	IMGN779 administered on days 1 and 15 of a 28-day cycle
Dose Escalation Schedule B	IMGN779	IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle
Dose Escalation Schedule C	IMGN779	IMGN779 administered on days 1 and 8 of a 21-day cycle
Dose Expansion Cohort	IMGN779	Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) of IMGN779	28 days

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Baylor Scott & White University Medical Center; 🇺🇸 Dallas, Texas, United States

The University of Texas, MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

New Mexico Cancer Care Alliance; 🇺🇸 Albuquerque, New Mexico, United States

Knight Cancer Institute - OSHU; 🇺🇸 Portland, Oregon, United States

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

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States