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

AbbVie

Status and phase

Terminated

Phase 1

Conditions

Colorectal Carcinoma

Glioblastoma Multiforme

Non-small Cell Lung Cancer

Triple Negative Breast Cancer

Head and Neck Squamous Cell Carcinoma

Treatments

Drug: ABBV-221

Study type

Interventional

Funder types

Industry

Identifiers

NCT02365662

M14-429

2014-003557-34 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

46 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.