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The drug ABR-217620 is a combination of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. In animals, this results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will test how much of the drug, in combination with docetaxel (an approved drug for treating non-small cell lung cancer [NSCLC]), can be given to patients with NSCLC without causing unacceptable side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABR-217620 | Drug | 10.3, 16.5 or 22 mcg/kg, IV, daily 5 minute bolus injection for 4 consecutive day per cycle; up to 6 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Side effect profile (based on blood pressure, body temperature, and laboratory tests) | Day 56 (Day 115 if undergo cycles 3/4) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | Days 1 and 4 of cycles 1 and 2 | |
| Immunological response | Day 56 (Day 115 if undergo cycles 3/4) | |
| Changes in anti-SEA/E-120 levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Kilany | Active Biotech AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States | ||
| Onkologisk Klinik, Rigshospitalet |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C543500 | naptumomab estafenatox |
| D017252 | CD3 Complex |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D000945 | Antigens, Differentiation, T-Lymphocyte |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
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| docetaxel | Drug | 75mg/m^2, IV, single 60 minute infusion, beginning on Day 5 then every third week |
|
|
| Day 56 (Day 115 if undergo cycles 3/4) |
| Objective response rate | Day 56 (Day 115 if undergo cycles 3/4) |
| Time to progression and Survival | Followed for up to 1 year |
| Copenhagen |
| Denmark |
| City Multifield Hospital #2, City Center of Intensive Pulmonology and Thoracic Surgery | Saint Petersburg | 194354 | Russia |
| St. Petersburg Pavlov State Medical University | Saint Petersburg | 197022 | Russia |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001685 | Biological Factors |
| D015415 | Biomarkers |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |