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Study of IMGN632 in Patients With Relapse/Refractory AML, BPDCN, ALL, Other CD123+ Hem Malignancies

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ClinicalTrials.gov Identifier: NCT03386513
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
ImmunoGen, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Lymphocytic Leukaemia Blastic Plasmacytoid Dendritic Cell Neoplasm Myeloproliferative Neoplasm Acute Myeloid Leukemia Drug: IMGN632 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multi-center, Open-label Study of IMGN632 Administered Intravenously in Patients With Relapsed/Refractory CD123-positive Acute Myeloid Leukemia and Other CD123-positive Hematologic Malignancies
Actual Study Start Date : January 4, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) and recommended Ph2 dose (RP2D) [ Time Frame: 28 Days ]
    To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of IMGN632 when administered as a single agent


Secondary Outcome Measures :
  1. Treatment emergent adverse events [ Time Frame: Up to 12 months ]
  2. Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR]) [ Time Frame: Up to 12 months ]
  3. PK parameters: maximum plasma concentration (Cmax) of IMGN632 [ Time Frame: Up to 12 months ]
  4. PK parameters: area under the time-concentration curve (AUC) of IMGN632 [ Time Frame: Up to 12 months ]
  5. PK parameters: terminal half-life (t½) of IMGN632 [ Time Frame: Up to 12 months ]
  6. Immunogenicity: Presence of Antibody-Drug Antibody (ADA) [ Time Frame: Up to 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 PDCN, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386513


Contacts
Contact: ImmunoGen Clinical Trials 781-895-0600 IMGN0801@immunogen.com

Locations
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030-7095
Contact: Study Coordinator    713-792-7321    JAlvarez1@mdanderson.org   
Principal Investigator: Hagop Kantarjian, MD         
Sponsors and Collaborators
ImmunoGen, Inc.
Jazz Pharmaceuticals
Investigators
Study Director: Patrick Zweidler-McKay, MD ImmunoGen, Inc.

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT03386513     History of Changes
Other Study ID Numbers: IMGN632-0801
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ImmunoGen, Inc.:
Antibody Drug Conjugate
Other Hematologic Malignancies
Myeloproliferative Neoplasms
CD123
MDS
Relapsed, Refractory
Acute Lymphocytic Leukaemia
Blastic Plasmacytoid Dendritic Cell Neoplasm
Acute Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Lymphoid
Myeloproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases