TerminatedPhase 1NCT02365662

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

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).

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

StatusTerminated
PhasePhase 1
U.S. locations5
SponsorAbbVie
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.

03
Public criteria

Who may be able to participate

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.

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.

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