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

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ClinicalTrials.gov Identifier: NCT02674763
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 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
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019


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



Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of IMGN779 [ Time Frame: 28 days ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674763


Contacts
Contact: ImmunoGen Clinical Operations IMGN601@immunogen.com

Locations
United States, Alabama
Comprehensive Cancer Center (UAB CCC) Recruiting
Birmingham, Alabama, United States, 35294
Contact: Harry Erba, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel DeAngelo, MD         
United States, New Mexico
New Mexico Cancer Care Alliance Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Cecilia Arana-Yi, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Eunice Wang, MD         
United States, Oregon
Knight Cancer Institute - OSHU Recruiting
Portland, Oregon, United States, 97239
Contact: Elie Traer, MD         
United States, Texas
The University of Texas, MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jorge Cortes, MD         
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Study Director: Patrick Zweidler-McKay, MD ImmunoGen, Inc.

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT02674763     History of Changes
Other Study ID Numbers: IMGN779 0601
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018

Keywords provided by ImmunoGen, Inc.:
Acute Myeloid Leukemia
AML
IMGN779
ImmunoGen
Phase 1
Relapsed
Refractory
CD33
Dose Escalation
Dose Expansion

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms