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The purpose of this study is to evaluate the safety, pharmacokinetics, anti-tumor activity, and identify a tolerable dose of AMG 228 in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 228 monotherapy | Experimental | Part 1 and Part 2 of the study will both be with single agent AMG 228 in different selected tumor types. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 228 | Drug | AMG 228 will be administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of dose limiting toxicities (DLT) | 9 months | |
| Subject incidence of treatment-emergent adverse events | 9 months | |
| Subject incidence of treatment-related adverse events | 9 months | |
| Subject incidence of clinically significant changes in vital signs and physical assessments | 9 months | |
| Subject incidence of clinically significant changes in ECGs | 9 months | |
| Subject incidence of clinically significant changes in clinical laboratory tests | 9 months | |
| AMG 228 maximum observed concentration (Cmax) | 9 months | |
| AMG 228 minimum observed concentration (Cmin) | 9 months | |
| AMG 228 area under the concentration-time curve (AUC) | 9 months | |
| AMG 228 half-life (t1/2) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject objective response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | 9 months | |
| Incidence of anti-AMG 228 antibody formation | 9 months | |
| Activation status and changes in numbers of T regulator cells (Treg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | La Jolla | California | 92093 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30253804 | Background | Tran B, Carvajal RD, Marabelle A, Patel SP, LoRusso PM, Rasmussen E, Juan G, Upreti VV, Beers C, Ngarmchamnanrith G, Schoffski P. Dose escalation results from a first-in-human, phase 1 study of glucocorticoid-induced TNF receptor-related protein agonist AMG 228 in patients with advanced solid tumors. J Immunother Cancer. 2018 Sep 25;6(1):93. doi: 10.1186/s40425-018-0407-x. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| 9 months |
| Subject objective response per immune-related Response Criteria (irRC) | 9 months |
| Activation status of cytotoxic T lymphocytes (CTL) | 9 months |
| Changes in numbers of cytotoxic T lymphocytes (CTL) | 9 months |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Research Site | New York | New York | 10032 | United States |
| Research Site | Parkville | Victoria | 3050 | Australia |
| Research Site | Leuven | 3000 | Belgium |
| Research Site | Villejuif | 94805 | France |
| Research Site | Heidelberg | 69120 | Germany |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D015179 | Colorectal Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
| D006258 | Head and Neck Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D018307 | Neoplasms, Squamous Cell |
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