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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
ABT-806 will be administered by intravenous infusion.
Site Reference ID/Investigator# 54056
Baltimore, Maryland, United States
Site Reference ID/Investigator# 41931
Boston, Massachusetts, United States
Site Reference ID/Investigator# 43422
Tacoma, Washington, United States
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)
Time frame: 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
Time frame: 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
Time frame: Week 1, 3, 5, 7, 11, 13, 15, 19, 23 and 30 Day Follow-up
Pharmacokinetic profile (assay for Anti-drug Antibody) Dose Escalation Cohort
Assay for Anti-drug antibody against ABT-806
Time frame: Week 1, 3, 7, 11, 15, 19, 23 and Final Visit
QT assessment
Triplicate ECGs
Time frame: Week 1, 7, 13, and 30 day follow-up visit
Infusion rate evaluation (Expanded Safety Cohort)
Two infusion times explored
Time frame: Every other week
Pharmacokinetic profile (assay for Anti-drug Antibody) Expanded Safety Cohort
Assay for Anti-drug antibody against ABT-806
Time frame: Week 1, 3, 7, 11, 15, 19, 23 and 30 Day Follow-up
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