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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-09

Study Completion Date

2018-03-15

Brief Summary

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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).

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor

Group Type EXPERIMENTAL

ABBV-221

Intervention Type DRUG

ABBV-221 will be given either every 3 weeks or 2 weeks on, 1 week off or weekly dosing by intravenous infusion approximately over 30 minutes to 3 hours. This is a dose escalation study, therefore the dose of ABBV-221 will change throughout the study.

Interventions

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ABBV-221

ABBV-221 will be given either every 3 weeks or 2 weeks on, 1 week off or weekly dosing by intravenous infusion approximately over 30 minutes to 3 hours. This is a dose escalation study, therefore the dose of ABBV-221 will change throughout the study.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No