This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications, is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
ABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700.
Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.
5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.
To evaluate the safety and tolerability of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Evaluation of vital signs, clinical lab testing, physical exams and adverse event monitoring
Time frame: First cycle of treatment through 60 day follow-up visit
To Evaluate the pharmacokinetics of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Pharmacokinetic profile of ABT-700 analyzed from blood samples
Time frame: At each cycle of treatment through 60 days after last dose.
To determine the recommended Phase 2 dose for ABT-700
Time frame: First cycle of treatment through 60 day follow-up visit
To evaluate the preliminary efficacy of ABT-700 when administered as monotherapy and in combination with docetaxel or 5-fluoruracil, folinic acid, irinotecan and cetuximab (FOLFIRI/cetuximab) or erlotinib
Objective response rate (complete and partial response), progression-free survival and duration of response
Time frame: Screening through 60 day follow-up visit
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Cetuximab will be administered by intravenous infusion weekly.
Erlotinib will be taken orally daily.
ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.