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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 : September 5, 2019
Sponsor:
Collaborator:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
ImmunoGen, Inc.

Tracking Information
First Submitted Date  ICMJE December 21, 2017
First Posted Date  ICMJE December 29, 2017
Last Update Posted Date September 5, 2019
Actual Study Start Date  ICMJE January 2, 2018
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 28, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03386513 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 28, 2017)
  • Treatment emergent adverse events [ Time Frame: Up to 12 months ]
  • Objective Response Rate (ORR) (complete response [CR= CR+CRp+CRi]+partial remission [PR]) [ Time Frame: Up to 12 months ]
  • PK parameters: maximum plasma concentration (Cmax) of IMGN632 [ Time Frame: Up to 12 months ]
  • PK parameters: area under the time-concentration curve (AUC) of IMGN632 [ Time Frame: Up to 12 months ]
  • PK parameters: terminal half-life (t½) of IMGN632 [ Time Frame: Up to 12 months ]
  • Immunogenicity: Presence of Antibody-Drug Antibody (ADA) [ Time Frame: Up to 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of IMGN632 in Patients With Relapse/Refractory AML, BPDCN, ALL, Other CD123+ Hem Malignancies
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Lymphocytic Leukaemia
  • Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Myeloproliferative Neoplasm
  • Acute Myeloid Leukemia
Intervention  ICMJE Drug: IMGN632
CD123-targeted ADC
Study Arms  ICMJE Experimental: Escalation and Expansion

Escalation: IMGN632 will be administered by IV on two different schedules for patients with relapsed/refractory AML or BPDCN:

Schedule A: Day 1 of each cycle, with cycles repeating every 21 days

Schedule B: Days 1, 4 and 8 of each cycle, with cycles repeating every 21 days

Expansion: IMGN632 will be administered based on the recommended phase 2 dose (RP2D) and schedule as determined in the Escalation Phase, across five expansion cohorts, for patients with relapsed BPDCN, AML, ALL, and other CD123+ hematologic malignancies.

Intervention: Drug: IMGN632
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 28, 2017)
155
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Disease Characteristics and allowable prior therapy:

  • Patients in dose escalation and all expansion cohorts (except relapsed AML in dose expansion) may have received up to three prior lines of therapy.
  • Patients with relapsed AML (dose expansion only) may have received up to two 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+ malignancies.
  • Dose Expansion Cohort #1 - Patients will have relapsed or refractory 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 relapsed CD123+ AML.
  • Dose Expansion Cohort #3 - Patients will have relapsed CD123+ ALL.
  • Dose Expansion Cohort #4 - Patients will have relapsed other CD123+ 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 Sponsor.
  • Dose Expansion Cohort #5 - Patients will have relapsed CD123+ AML.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ImmunoGen Clinical Trials 781-895-0115 medicalaffairs@immunogen.com
Listed Location Countries  ICMJE France,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03386513
Other Study ID Numbers  ICMJE IMGN632-0801
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ImmunoGen, Inc.
Study Sponsor  ICMJE ImmunoGen, Inc.
Collaborators  ICMJE Jazz Pharmaceuticals
Investigators  ICMJE
Study Director: Patrick Zweidler-McKay, MD ImmunoGen, Inc.
PRS Account ImmunoGen, Inc.
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP