Clinical trial NCT02365662: 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
Official title: A Phase 1 Study of ABBV-221 in Subjects With Advanced Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Head and Neck Squamous Cell Carcinoma
Non-small Cell Lung Cancer
Triple Negative Breast Cancer
Colorectal Carcinoma
Glioblastoma Multiforme
Keywords: Oncology
Cancer
Solid Tumor types likely to exhibit elevated levels of Epidermal Growth Factor Receptor
Solid Tumors
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Measured for approximately 4 years
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).
measure: Area Under the Plasma Concentration-time Curve from 0 to the Time of the Last Measurable Concentration (AUCt) 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).
measure: Maximum tolerated dose of ABBV-221
timeFrame: Up to 2 years from first dose of study drug.
measure: Area Under the Plasma Concentration-time Curve 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).
measure: Recommended Phase 2 dose of ABBV-221
timeFrame: 1 day of study drug administration within the 21-day cycle at the designated cohort dose
Secondary outcomes:
measure: Assess the effect of systemic ABBV-221 administration on QT prolongation
timeFrame: At Days 1, 2, 3, 5, 8 of Cycle 1; Day 1 of every cycle starting at Cycle 2, and Final Visit (approximately 2 years from first dose of study drug)
measure: Objective Response Rate (ORR)
timeFrame: At screening; at the end of Cycle 2 and the end of every 3 cycles for approximately 2 years from first dose of study drug
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hosp Univ Madrid Sanchinarro
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: