Study of IMGN632 in Patients with CD123-positive AML and other CD123-positive Hematologic cancers
Research type
Research Study
Full title
A Phase 1/2, Multi-center, Open-label Study of IMGN632 Monotherapy Administered Intravenously in Patients with CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
IRAS ID
1004845
Contact name
Anna Berkenblit
Contact email
Sponsor organisation
ImmunoGen, Inc.
Eudract number
2018-003210-40
Clinicaltrials.gov Identifier
Research summary
Study IMGN632-0801 is an open-label, multicentre, Phase 1/2 study to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) if different, and recommended dosing schedule for IMGN632 monotherapy and to assess the safety, tolerability, PK, immunogenicity, and anti-leukaemia activity of IMGN632 when administered to patients with CD123+ malignancies. This study is comprised of a dose escalation phase followed by a dose expansion phase. The dose escalation phase investigated different dosing schedules and the dose expansion phase explored further the safety profile and anti-leukaemia activity at selected RP2Ds and recommended schedule(s). The dose expansion phase is currently only enrolling patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) at the RP2D of 0.045 mg/kg for Cohorts 1 and 6, administered on Day 1 of a 21-day cycle.
A cumulative total of 228 patients have been exposed to IMGN632, with a total of 140 patients exposed in the IMGN632-0801 study as of 6th October 2021 which is currently being run in the United States, France, Italy and Spain. Patients enrolled in the United Kingdom are expected to participate in the dose expansion phase of the study only. The study will be conducted at two centres in the UK with Dr. Andrew Peniket at Churchill Hospital, Oxford University Hospitals, serving as national coordinating investigator.
The investigational medicinal product, IMGN632, targets tumours by delivering a cell-killing drug to the cancerous blast cells carrying a leukaemia-associated protein called CD123. The CD123 antigen is overexpressed in multiple hematologic malignancies of both myeloid and lymphoid origin, including AML (acute myeloid leukaemia), BPDCN, as well as other hematologic malignancies.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0094
Date of REC Opinion
23 Jun 2022
REC opinion
Further Information Favourable Opinion