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TerminatedPhase 1NCT02365662
Official study title

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 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).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedABBV-221

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 30, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?AbbVie

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
AbbVie
Interventions being studied
Drug: ABBV-221
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
EGFR→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General HospitalBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • South Texas Accelerated Research TherapeuticsSan Antonio, Texas
  • Fundacion Jimenez DiazMadrid
  • Hosp Univ Madrid SanchinarroMadrid

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 30, 2018. Always confirm current availability with the study team.

View original record ↗