Overview

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

Status:
Completed
Trial end date:
2019-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ImmunoGen, Inc.
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