A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by ImmunoGen, Inc.
Sponsor:
Information provided by (Responsible Party):
ImmunoGen, Inc.
ClinicalTrials.gov Identifier:
NCT01963715
First received: October 9, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.


Condition Intervention Phase
EGFR Positive Solid Tumors
Drug: IMGN289
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors

Resource links provided by NLM:


Further study details as provided by ImmunoGen, Inc.:

Primary Outcome Measures:
  • Number of participants with dose limiting toxicities [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
  • Area under the plasma concentration versus time curve [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Determine the amount of IMGN289 in participants blood (pharmacokinetics)

  • Peak plasma concentration (Cmax) of IMGN289 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Determine the amount of IMGN289 in participants blood (pharmacokinetics)

  • Presence of Human Anti Human Antibody and Human Anti Drug Antibody [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Assess whether participants develop an immune response to IMGN289

  • Tumor measurements per RECIST 1:1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Assess preliminary anti-tumor activity


Estimated Enrollment: 86
Study Start Date: October 2013
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGFR+ Solid Tumor
EGFR+ Solid Tumor
Drug: IMGN289

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years old at time of consent
  • Diagnosed with a solid tumor that has progressed despite standard therapy or for which no standard effective or curative options exist or are suitable
  • EGFR-positive tumor expression
  • Adequate blood and organ function
  • Must agree to use contraception while on study and for 12 weeks after the last dose of IMGN289 as applicable
  • Must be willing and able to sign informed consent and follow the study schedule and other protocol requirements

Exclusion Criteria:

  • Other anti-cancer treatment during the study
  • Symptomatic brain metastases
  • Other clinically significant disease as defined by the protocol
  • Chronic skin condition that requires prescribed oral or intravenous treatment
  • History of severe rash that required discontinuation of prior EGFR targeted therapy
  • Receiving therapeutic doses of warfarin or heparin for anti-coagulation
  • Known diagnosis of HIV or active viral hepatitis
  • Women who are pregnant or breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963715

Contacts
Contact: Andrea Vergara-Silva, MD 781-895-0600 imgn0501trial@immunogen.com

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Elizabeth Olson    310-967-4334    elizabeth.olson2@cshs.org   
Principal Investigator: Alain C Mita, MD         
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Sandra West       swest8@jhmi.edu   
Principal Investigator: Hyunseok Kang, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Rudo Makonza-Goto    617-632-6284    rudo_makonzagoto@dfci.harvard.edu   
Principal Investigator: Leena Gandhi, MD, PhD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Delaney Erickson    313-576-9806    ericksod@karmanos.org   
Principal Investigator: Patricia M LoRusso, DO         
Sponsors and Collaborators
ImmunoGen, Inc.
Investigators
Study Director: Andrea Vergara-Silva, MD ImmunoGen, Inc.
  More Information

No publications provided

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT01963715     History of Changes
Other Study ID Numbers: IMGN0501
Study First Received: October 9, 2013
Last Updated: August 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ImmunoGen, Inc.:
IMGN289
Antibody Drug Conjugate
antibody
EGFR
NSCLC
SCCHN
Head and neck
Squamous cell carcinoma
Solid tumor
Immunogen
Lung
Phase 1

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 28, 2014