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

Purpose

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

  • Acute Myeloid Leukemia

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
ImmunoGen, Inc.

Study Contact

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.