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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.

February 1, 2016
February 4, 2016
June 18, 2018
March 2016
December 2018   (Final data collection date for primary outcome measure)
Maximum Tolerated Dose (MTD) of IMGN779 [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT02674763 on ClinicalTrials.gov Archive Site
  • Treatment emergent adverse events [ Time Frame: Up to 12 months ]
  • Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR]) [ Time Frame: Up to 12 months ]
  • PK parameters: maximum plasma concentration (Cmax) of IMGN779 [ Time Frame: up to 12 months ]
  • PK parameters: area under the time-concentration curve (AUC) of IMGN779 [ Time Frame: Up to 12 months ]
  • PK parameters: terminal half-life (t½) of IMGN779 [ Time Frame: Up to 12 months ]
  • Immunogenicity: Presence of Antibody-Drug Antibody (ADA) [ Time Frame: Up to 12 months ]
Same as current
Not Provided
Not Provided
 
Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously 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.
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.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
Drug: IMGN779
  • Experimental: Dose Escalation Schedule A
    IMGN779 administered on days 1 and 15 of a 28-day cycle
    Intervention: Drug: IMGN779
  • Experimental: Dose Escalation Schedule B
    IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle
    Intervention: Drug: IMGN779
  • Experimental: Dose Escalation Schedule C
    IMGN779 administered on days 1 and 8 of a 21-day cycle
    Intervention: Drug: IMGN779
  • Experimental: Dose Expansion Cohort
    Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.
    Intervention: Drug: IMGN779
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
104
124
March 2019
December 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: ImmunoGen Clinical Operations IMGN601@immunogen.com
United States
 
 
NCT02674763
IMGN779 0601
Yes
Not Provided
Not Provided
ImmunoGen, Inc.
ImmunoGen, Inc.
Not Provided
Study Director: Patrick Zweidler-McKay, MD ImmunoGen, Inc.
ImmunoGen, Inc.
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP