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This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-7475+GnP | Experimental |
| |
| ONO-7475＋ONO-4538＋GnP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-7475 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities (DLT) | 28 days | |
| Adverse event (AE) | Up to 28 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Plasma concentration of ONO-7475) | Up to Cycle16 | |
| Pharmacokinetics (Plasma concentration of ONO-4538) | Through study completion, an average of 6 months | |
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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 |
|---|---|---|---|---|---|---|
| Aichi Cancer Center | Nagoya | Aichi-ken | Japan | |||
| National Cancer Center Hospital East |
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| ONO-4538 |
| Drug |
Specified dose on specified days |
|
|
| Nab-paclitaxel | Drug | Specified dose on specified days |
|
| Gemcitabine | Drug | Specified dose on specified days |
|
| Anti-ONO-4538 antibody |
| Through study completion, an average of 6 months |
| Objective Response Rate (ORR) | Through study completion, an average of 6 months |
| Disease Control Rate (DCR) | Through study completion, an average of 6 months |
| Overall Survival (OS) | Through study completion, an average of 1 year |
| Progression-Free Survival (PFS) | Through study completion, an average of 6 months |
| Duration of Response (DOR) | Through study completion, an average of 6 months |
| Time to Response (TTR) | Through study completion, an average of 6 months |
| Best Overall Response (BOR) | Through study completion, an average of 6 months |
| Percent change in the sum diameters of the target lesions | Through study completion, an average of 6 months |
| Maximum percent change in the sum diameters of the target lesions | Through study completion, an average of 6 months |
| CEA | Through study completion, an average of 6 months |
| CA19-9 | Through study completion, an average of 6 months |
| Kashiwa-shi |
| Chiba |
| Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | Japan |
| Kanagawa Cancer Center | Yokohama | Kanagawa | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | Japan |
| Seirei Hamamatsu General Hospital | Hamamatsu | Shizuoka | Japan |
| Juntendo University Hpspital | Bunkyo-ku | Tokyo | Japan |
| The University of Tokyo Hospital | Bunkyo-ku | Tokyo | Japan |
| The Cancer Institute Hospital Of JFCR | Koto-Ku | Tokyo | Japan |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C520255 | 130-nm albumin-bound paclitaxel |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| 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 |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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