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

Sponsor

ImmunoGen, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02674763

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

8.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: IMGN779	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Jun 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Maximum Tolerated Dose (MTD) of IMGN779 [28 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Cancer Center (UAB CCC)	Birmingham	Alabama	United States	35294
2	Dana-Farber Cancer Institute	Boston	Massachusetts	United States	02215
3	New Mexico Cancer Care Alliance	Albuquerque	New Mexico	United States	87106
4	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
5	Knight Cancer Institute - OSHU	Portland	Oregon	United States	97239
6	Baylor Scott & White University Medical Center	Dallas	Texas	United States	75246
7	The University of Texas, MD Anderson Cancer Center	Houston	Texas	United States	77030