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



Status:Terminated
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:April 2015

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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.


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
We found this trial at
4
sites
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Detroit, Michigan 48201
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Detroit, MI
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