NCT02674763

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

September 4, 2019

Status Verified

September 1, 2019

Enrollment Period

3.3 years

First QC Date

February 1, 2016

Last Update Submit

September 3, 2019

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid LeukemiaAMLIMGN779ImmunoGenPhase 1RelapsedRefractoryCD33Dose EscalationDose Expansion

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose (MTD) of IMGN779

    28 days

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (4)

Dose Escalation Schedule A

EXPERIMENTAL

IMGN779 administered on days 1 and 15 of a 28-day cycle

Drug: IMGN779

Dose Escalation Schedule B

EXPERIMENTAL

IMGN779 administered on days 1, 8, 15 and 22 of a 28-day cycle

Drug: IMGN779

Dose Escalation Schedule C

EXPERIMENTAL

IMGN779 administered on days 1 and 8 of a 21-day cycle

Drug: IMGN779

Dose Expansion Cohort

EXPERIMENTAL

Patients with Relapsed AML; IMGN779 administered at dose and schedule selected as the putative RP2D.

Drug: IMGN779

Interventions

IMGN779DRUG
Dose Escalation Schedule ADose Escalation Schedule BDose Escalation Schedule CDose Expansion Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Comprehensive Cancer Center (UAB CCC)

Birmingham, Alabama, 35294, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

New Mexico Cancer Care Alliance

Albuquerque, New Mexico, 87106, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Knight Cancer Institute - OSHU

Portland, Oregon, 97239, United States

Location

Baylor Scott & White University Medical Center

Dallas, Texas, 75246, United States

Location

The University of Texas, MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteRecurrence

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick Zweidler-McKay, MD

    ImmunoGen, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 4, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2019

Study Completion

July 1, 2019

Last Updated

September 4, 2019

Record last verified: 2019-09

Locations

US(7)