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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | ABT-700 will be administered by intravenous infusion at escalating dose levels in 21-day dosing cycles. Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-700. |
|
| Cohort B | Experimental | ABT-700 plus docetaxel. |
|
| Cohort C | Experimental | ABT-700 plus FOLFIRI/cetuximab |
|
| Cohort D | Experimental | ABT-700 plus erlotinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-700 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | At each cycle of treatment through 60 days after last dose. |
| To determine the recommended Phase 2 dose for ABT-700 | First cycle of treatment through 60 day follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Screening through 60 day follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louie Naumovski, MD | AbbVie | Study Director |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000626235 | telisotuzumab vedotin |
| D000077143 | Docetaxel |
| C480833 | IFL protocol |
| D000068818 | Cetuximab |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| docetaxel | Drug | Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles. |
|
| FOLFIRI | Drug | 5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles. |
|
| cetuximab | Drug | Cetuximab will be administered by intravenous infusion weekly. |
|
| erlotinib | Drug | Erlotinib will be taken orally daily. |
|
| ABT-700 | Drug | ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles. |
|
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |