A Phase 1 interventional study of ABBV-221 in Head and Neck Squamous Cell Carcinoma, Non-small Cell Lung Cancer and Triple Negative Breast Cancer, sponsored by AbbVie. Terminated at 5 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-03-30.
Sponsored by AbbVie · Phase 1, Interventional, and Treatment
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).
6,738 studies on the registry are indexed under Carcinoma; 1,159 are open to participants now.
This study's enrollment of 46 is close to the median of 45 across 5,167 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
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Exclusion Criteria:
Solid Tumor Types Likely to Exhibit Elevated Levels of Epidermal Growth Factor Receptor
Drug: ABBV-221
ABBV-221 will be given either every 3 weeks or 2 weeks on, 1 week off or weekly dosing by intravenous infusion approximately over 30 minutes to 3 hours. This is a dose escalation study, therefore the dose of ABBV-221 will change throughout the study.
Number of participants with adverse events
Adverse event monitoring will be performed during the study
Time frame: Measured for approximately 4 years
Maximum Plasma Concentration (Cmax) of ABBV-221
The maximum plasma concentration (Cmax; measured in ng/mL) is the highest concentration that a drug achieves in the plasma after administration in a dosing interval.
Time frame: 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).
Area Under the Plasma Concentration-time Curve from 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-221
The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
Time frame: 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).
Maximum tolerated dose of ABBV-221
The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Time frame: Up to 2 years from first dose of study drug.
Area Under the Plasma Concentration-time Curve of ABBV-221
The area under the plasma concentration-time curve (AUC; measured in ng\*hr/mL) is a method of measurement of the total exposure of a drug in blood plasma.
Time frame: 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).
Recommended Phase 2 dose of ABBV-221
If a maximum tolerated dose (MTD) is reached, the recommended Phase 2 dose (RPTD) of ABBV-221 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
Time frame: 1 day of study drug administration within the 21-day cycle at the designated cohort dose
Assess the effect of systemic ABBV-221 administration on QT prolongation
ECG parameters will be descriptively summarized, and the relationship between change of baseline of QT interval corrected for heart rate and concentration of three analytes will be explored.
Time frame: 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)
Objective Response Rate (ORR)
ORR is the proportion of participants with objective response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (complete or partial objective response) will be calculated for all dosed participants with at least one measurable lesion at baseline.
Time frame: 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
Plan to share: Undecided
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This study is terminated, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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