A Study Evaluating Safety and Pharmacokinetics of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Stopped early · Phase 1

Conditions studied: Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Colorectal Carcinoma, Glioblastoma Multiforme

In brief

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).

Key facts

Study ID

NCT02365662

Run by

AbbVie

People needed

46

Starts

2015-01-09

Expected to finish

2018-03-15

Last updated by the study team

2018-03-30

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States
• Fundacion Jimenez Diaz — Madrid, Spain
• Hosp Univ Madrid Sanchinarro — Madrid, Spain

Full record on ClinicalTrials.gov

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