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



Status:Terminated
Conditions:Breast Cancer, Lung Cancer, Colorectal Cancer, Cancer, Cancer, Cancer, Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:4/17/2018
Start Date:January 9, 2015
End Date:March 15, 2018

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A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

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).


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.
We found this trial at
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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2 Avenida de los Reyes Católicos
Madrid, 28040
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