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To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-7475 monotherapy | Experimental |
| |
| ONO-7475 in combination with ONO-4538 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-7475 | Drug | ONO-7475 specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of paticipants with dose-limiting toxicities during the DLT evaluation period | 28 days | |
| Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Cmax) | Assessment of the maximum plasma concentration of ONO-7475 both alone and in combination with ONO-4538 | Through study completion |
| Pharmacokinetics (Tmax) | Assessment of the time to reach maximum observed plasma concentration of ONO-7475 both alone and in combination with ONO-4538 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Clinical Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39779468 | Derived | Zhao X, Li Y, Yang S, Chen Y, Wu K, Geng J, Liu P, Wang Z, Dai H, Wang C. Orderly Regulation of Macrophages and Fibroblasts by Axl in Bleomycin-Induced Pulmonary Fibrosis in Mice. J Cell Mol Med. 2025 Jan;29(1):e70321. doi: 10.1111/jcmm.70321. |
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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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| ONO-7475 + ONO-4538 |
| Drug |
ONO-7475+ONO-4538 specified dose on specified days |
|
| Through study completion |
| Pharmacokinetics (AUC) | Assessment of the plasma area under the curve of ONO-7475 both alone and in combination with ONO-4538 | Through study completion |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |