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The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4538 1mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle |
|
| ONO-4538 3mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle |
|
| ONO-4538 10mg/kg | Experimental | ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4538 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome: The number of subjects with overall adverse events | Approximately 6 months | |
| Safety outcome: The number of deaths | Approximately 6 months | |
| PK outcome: Cmax of ONO-4538 | Approximately 10 months | |
| Efficacy outcome: Response rate | Approximately 6 months | |
| Efficacy outcome: Progression free survival | Approximately 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitsunobu Tanimoto | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seongnam-si Clinical Site 105 | Seongnam-si | Gyeonggi-do | South Korea | |||
| Seoul Clinical Site 101 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29158363 | Derived | Lee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20. |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Seoul |
| South Korea |
| Seoul Clinical Site 102 | Seoul | South Korea |
| Seoul Clinical Site 103 | Seoul | South Korea |
| Seoul Clinical Site 104 | Seoul | South Korea |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |