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This is an open-label study designed to determine the recommended Phase 2 dose (RPTD) and evaluate the safety and pharmacokinetics of ABT-806 in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-806 Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-806 | Drug | ABT-806 will be administered by intravenous infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (Number of subjects with adverse events and/or dose-limiting toxicities) | Evaluation of vital signs, clinical lab testing and adverse event monitoring (every other week), physical exam (every 4 weeks) and ECG (periodic) | At each treatment visit (weekly for first 4 weeks and then at least every 4 weeks through end of treatment) |
| Pharmacokinetic profile (assay for ABT-806) Dose Escalation Cohort | Assay for ABT-806 | Week 1, 2, 3, 5, 7, 8, 9, 11, 13, 15, 19, 23 and Final Visit |
| Pharmacokinetic profile (assay for ABT-806) Expanded Safety Cohort | Assay for ABT-806 | Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort | Assay for Anti-drug antibody against ABT-806 | Week 1, 3, 7, 11, 15, 19, 23 and Final Visit |
| QT assessment | Triplicate ECGs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle D. Holen, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 54056 | Baltimore | Maryland | 21231 | United States | ||
| Site Reference ID/Investigator# 41931 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25761639 | Result | Sharma S, Mittapalli RK, Holen KD, Xiong H. Population Pharmacokinetics of ABT-806, an Investigational Anti-Epidermal Growth Factor Receptor (EGFR) Monoclonal Antibody, in Advanced Solid Tumor Types Likely to Either Over-Express Wild-Type EGFR or Express Variant III Mutant EGFR. Clin Pharmacokinet. 2015 Oct;54(10):1071-81. doi: 10.1007/s40262-015-0258-2. |
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| ID | Term |
|---|---|
| C000604456 | depatuxizumab |
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| Week 1, 7, 13, and 30 day follow-up visit |
| Infusion rate evaluation (Expanded Safety Cohort) | Two infusion times explored | Every other week |
| Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort | Assay for Anti-drug antibody against ABT-806 | Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Site Reference ID/Investigator# 43422 | Tacoma | Washington | 98405 | United States |