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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01963715
Recruitment Status : Terminated
First Posted : October 16, 2013
Last Update Posted : October 2, 2015
Information provided by (Responsible Party):

October 9, 2013
October 16, 2013
October 2, 2015
October 2013
April 2015   (Final data collection date for primary outcome measure)
Number of participants with dose limiting toxicities [ Time Frame: Up to 2 years ]
Same as current
Complete list of historical versions of study NCT01963715 on ClinicalTrials.gov Archive Site
  • Number of participants with adverse events [ Time Frame: Up to 2 years ]
  • Area under the plasma concentration versus time curve [ Time Frame: Up to 2 years ]
    Determine the amount of IMGN289 in participants blood (pharmacokinetics)
  • Peak plasma concentration (Cmax) of IMGN289 [ Time Frame: Up to 2 years ]
    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 ]
    Assess whether participants develop an immune response to IMGN289
  • Tumor measurements per RECIST 1:1 [ Time Frame: Up to 2 years ]
    Assess preliminary anti-tumor activity
Same as current
Not Provided
Not Provided
A Phase 1 Study of IMGN289 in Adult Patients With EGFR-positive Solid Tumors
A Phase 1, Multi-center, Open-label Study of IMGN289 Administered Intravenously in Adult Patients With EGFR-positive Solid Tumors
This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
EGFR Positive Solid Tumors
Drug: IMGN289
Experimental: EGFR+ Solid Tumor
EGFR+ Solid Tumor
Intervention: Drug: IMGN289
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
ImmunoGen, Inc.
ImmunoGen, Inc.
Not Provided
Study Director: Andrea Vergara-Silva, MD ImmunoGen, Inc.
ImmunoGen, Inc.
September 2015

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