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

A Phase 1, Multi-center, Open-label Study of IMGN779 Administered Intravenously in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02674763

Enrollment

Registered

2016-02-04

Start date

2016-03-31

Completion date

2019-07-31

Last updated

2019-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia, AML, IMGN779, ImmunoGen, Phase 1, Relapsed, Refractory, CD33, Dose Escalation, Dose Expansion

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.

Interventions

DRUGIMGN779

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Maximum Tolerated Dose (MTD) of IMGN779	28 days

Secondary

Measure	Time frame
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
Treatment emergent adverse events	Up to 12 months
PK parameters: terminal half-life (t½) of IMGN779	Up to 12 months
Immunogenicity: Presence of Antibody-Drug Antibody (ADA)	Up to 12 months
PK parameters: area under the time-concentration curve (AUC) of IMGN779	Up to 12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026