Clinical trial NCT02674763: Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
AML
IMGN779
ImmunoGen
Phase 1
Relapsed
Refractory
CD33
Dose Escalation
Dose Expansion
Lead sponsor: ImmunoGen, Inc.
Sponsor class: INDUSTRY
First posted: 2016-02-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of IMGN779
timeFrame: 28 days
Secondary outcomes:
measure: Treatment emergent adverse events
timeFrame: Up to 12 months
measure: Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR])
timeFrame: Up to 12 months
measure: PK parameters: maximum plasma concentration (Cmax) of IMGN779
timeFrame: up to 12 months
measure: PK parameters: area under the time-concentration curve (AUC) of IMGN779
timeFrame: Up to 12 months
measure: PK parameters: terminal half-life (t½) of IMGN779
timeFrame: Up to 12 months
measure: Immunogenicity: Presence of Antibody-Drug Antibody (ADA)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Comprehensive Cancer Center (UAB CCC)
state: Alabama
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Albuquerque
country: United States
facility: New Mexico Cancer Care Alliance
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Portland
country: United States
facility: Knight Cancer Institute - OSHU
state: Oregon
city: Dallas
country: United States
facility: Baylor Scott & White University Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas, MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: ImmunoGen, Inc.
name: Patrick Zweidler-McKay, MD
role: STUDY_DIRECTOR
References: