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TerminatedPhase 1NCT01963715
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIMGN289

The study team can explain what participation involves.

Who it may be forEGFR

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 2, 2015 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?4 U.S. locations

Locations may change over time.

Who runs it?ImmunoGen, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
ImmunoGen, Inc.
Interventions being studied
Drug: IMGN289
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
EGFR→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Cedars-Sinai Medical CenterLos Angeles, California
  • Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Karmanos Cancer InstituteDetroit, Michigan

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 2, 2015. Always confirm current availability with the study team.

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