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

September 30, 2015 updated by: ImmunoGen, Inc.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EGFR+ Solid Tumor
Drug: IMGN289

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with dose limiting toxicities
Time Frame: Up to 2 years
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: Up to 2 years
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)
Up to 2 years
Peak plasma concentration (Cmax) of IMGN289
Time Frame: Up to 2 years
Determine the amount of IMGN289 in participants blood (pharmacokinetics)
Up to 2 years
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
Up to 2 years
Tumor measurements per RECIST 1:1
Time Frame: Up to 2 years
Assess preliminary anti-tumor activity
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmunoGen, Inc.

Investigators

  • Study Director: Andrea Vergara-Silva, MD, ImmunoGen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

October 9, 2013

First Submitted That Met QC Criteria

October 11, 2013

First Posted (ESTIMATE)

October 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMGN0501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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