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

October 9, 2013
August 19, 2014
October 2013
June 2017   (final data collection date for primary outcome measure)
Number of participants with dose limiting toxicities [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
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 ] [ 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
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
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
86
Not Provided
June 2017   (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
Both
18 Years and older
No
Contact: Andrea Vergara-Silva, MD 781-895-0600 imgn0501trial@immunogen.com
United States
 
NCT01963715
IMGN0501
No
ImmunoGen, Inc.
ImmunoGen, Inc.
Not Provided
Study Director: Andrea Vergara-Silva, MD ImmunoGen, Inc.
ImmunoGen, Inc.
August 2014

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