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

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT01963715 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-497

 

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

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Leena Gandhi, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility 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
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