Clinical trial · Interventional
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
A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
NCT02365662CI-TRIAL-00032289terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Safety
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABBV-221 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
- interventionNames
- Drug: ABBV-221
Primary outcomes (6)
- measure
- Number of participants with adverse events
- timeFrame
- Measured for approximately 4 years
- description
- Adverse event monitoring will be performed during the study
- measure
- Maximum Plasma Concentration (Cmax) of ABBV-221
- timeFrame
- Blood samples will be collected before infusion (0 hour, pre-dose) on Cycle 1 Day 1 (C1D1), C1D2, C1D3, C1D5, C1D8, C1D15, C2D1, C3D1, C3D2, C3D3, C3D5, C3D8, C3D15, every 2 cycles starting with Cycle 5, and at the final visit (approximately 2 years).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.