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

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ImmunoGen, Inc.
• Treatments: Antibodies

Criteria

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