Purpose

This is an open-label, multi-center, Phase 1 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and preliminary anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.

Conditions

Eligibility

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

Inclusion Criteria

  • Disease Characteristics and allowable prior therapy:
  • Patients in dose escalation and all expansion cohorts except first relapse AML may have received up to three prior lines of therapy.
  • Dose Escalation - Relapsed or refractory AML (excluding acute promyelocytic leukemia) or BPDCN, based on World Health Organization Classification. All patients enrolled on this study will have CD123+ disease.
  • Dose Expansion Cohort #1 - Patients will have relapse of CD123+ BPDCN. Patients with prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression.
  • Dose Expansion Cohort #2 - Patients will have first relapse of CD123+ AML.
  • Dose Expansion Cohort #3 - Patients will have relapse of CD123+ ALL.
  • Dose Expansion Cohort #4 - Patients will have relapse of CD123+ "other" hematologic malignancies not included in the cohorts above (e.g., high-risk/very high-risk MDS, MPN, CMML, CML blast crisis). Other CD123+ malignancies may be considered upon discussion with the Medical Monitor.

Exclusion Criteria

  • Patients who, in the judgment of their treating physician, have available standard of care therapies will be excluded
  • AML patients with active central nervous system (CNS) disease will be excluded.
  • Patients with a history of venous occlusive disease of the liver
  • Patients with a history of Grade 3-4 capillary leak syndrome, or non-cardiac Grade edema are ineligible, e.g., related to SL-401 or other etiology
  • Myocardial infarction within six months prior to enrollment or has New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities prior to study entry
  • Patients who have received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational agents within 14 days or five half-lives, whichever is greater (with exception of hydroxyurea), prior to drug administration on this study.

Study Design

Phase
Phase 1
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Escalation and Expansion
Escalation: IMGN632 will be administered by IV on Day 1 of each cycle, with cycles repeating every 21 days for patients with relapsed/refractory AML or BPDCN. Expansion: IMGN632 will be administered by IV on Day 1 of each cycle, with cycles repeating every 21 days, across four expansion cohorts, for patients with relapsed BPDCN, AML, ALL, and other CD123+ hematologic malignancies
  • Drug: IMGN632
    CD123-targeted ADC

Recruiting Locations

University of Alabama Birmingham
Birmingham, Alabama 35294
Contact:
Angel S Elliot, RN, BSN
205-975-8080
ansanders@uabmc.edu

More Details

NCT ID
NCT03386513
Status
Recruiting
Sponsor
ImmunoGen, Inc.

Study Contact

ImmunoGen Clinical Trials
781-895-0115
medicalaffairs@immunogen.com

Detailed Description

The study comprises a dose escalation phase followed by a dose expansion phase to further characterize the safety profile and confirm the MTD. IMGN632 will be administered IV on Day 1 of each cycle, with cycles repeating every 21 days. Treatment will continue for up to 2 cycles (6 weeks) in the absence of disease progression (PD), treatment intolerance, or withdrawal of consent.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.