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

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