Expired Study
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San Antonio, Texas 78229


Purpose:

This is an open-label, Phase I, dose escalation study to determine the recommended Phase 2 dose, maximum tolerated dose, and evaluate the safety and pharmacokinetic profile of ABBV-221 in participants with advanced solid tumors likely to exhibit elevated levels of Epidermal Growth Factor Receptor (EGFR).


Criteria:

Inclusion Criteria: - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2. - Has a solid tumor likely to exhibit elevated levels of EGFR (e.g. head and neck squamous cell carcinoma, non-small cell lung cancer, triple negative breast cancer ,colorectal carcinoma and glioblastoma multiforme). - Has an archived, diagnostic tumor tissue available for analysis. - Has adequate hematologic, renal, cardiac and hepatic function. - Expanded Safety Cohort participants must have confirmed metastatic lung cancer and progressed after receiving prior platinum-containing chemotherapy. Exclusion Criteria: - Previously received an EGFR-directed monoclonal antibody within the past 4 weeks. - Has unresolved, clinically significant toxicities from prior anti-cancer therapy defined as > Grade 1 on Common Terminology Criteria for Adverse Events. - History of major immunologic reaction to any IgG containing agent. - Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.


NCT ID:

NCT02365662


Primary Contact:

Study Director
AbbVie Inc.
AbbVie


Backup Contact:

N/A


Location Contact:

San Antonio, Texas 78229
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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