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

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ClinicalTrials.gov Identifier: NCT01963715
Recruitment Status : Terminated
First Posted : October 16, 2013
Last Update Posted : October 2, 2015
Information provided by (Responsible Party):
ImmunoGen, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
EGFR Positive Solid Tumors Drug: IMGN289 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2013
Primary Completion Date : April 2015
Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: EGFR+ Solid Tumor
EGFR+ Solid Tumor
Drug: IMGN289

Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities [ Time Frame: Up to 2 years ]

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

  3. Peak plasma concentration (Cmax) of IMGN289 [ Time Frame: Up to 2 years ]
    Determine the amount of IMGN289 in participants blood (pharmacokinetics)

  4. Presence of Human Anti Human Antibody and Human Anti Drug Antibody [ Time Frame: Up to 2 years ]
    Assess whether participants develop an immune response to IMGN289

  5. Tumor measurements per RECIST 1:1 [ Time Frame: Up to 2 years ]
    Assess preliminary anti-tumor activity

Information from the National Library of Medicine

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

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

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): NCT01963715

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
ImmunoGen, Inc.
Study Director: Andrea Vergara-Silva, MD ImmunoGen, Inc.

Responsible Party: ImmunoGen, Inc.
ClinicalTrials.gov Identifier: NCT01963715     History of Changes
Other Study ID Numbers: IMGN0501
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

Keywords provided by ImmunoGen, Inc.:
Antibody Drug Conjugate
Head and neck
Squamous cell carcinoma
Solid tumor
Phase 1

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs