Overview

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
Trial end date:
2018-03-15
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie
Treatments:
Mitogens
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.