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

ImmunoGen

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: IMGN779

Study type: Interventional

Funder types: Industry

Identifiers

NCT02674763

IMGN779 0601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 4 patient groups

Dose Escalation Schedule A

Experimental group

Description:

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

Treatment:

Drug: IMGN779

Dose Escalation Schedule B

Experimental group

Description:

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

Treatment:

Drug: IMGN779

Dose Escalation Schedule C

Experimental group

Description:

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

Treatment:

Drug: IMGN779

Dose Expansion Cohort

Experimental group

Description:

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

Treatment:

Drug: IMGN779