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 |
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).
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.
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