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
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- AbbVie
- Interventions being studied
- Drug: ABBV-221
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
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.