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

Stopped early · Phase 1

Conditions studied: EGFR Positive Solid Tumors

In brief

This is a Phase 1, first-in-human study to determine the recommended dose of IMGN289 in adult patients with advanced EGFR-positive tumors.

Key facts

Study ID: NCT01963715
Run by: ImmunoGen, Inc.
People needed: 20
Starts: 2013-10-01
Expected to finish: 2015-04-01
Last updated by the study team: 2015-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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