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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2080223441 | Registry Identifier | Japan Registry of Clinical Trials |
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The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (Dose Escalation Part): ONO-4578 monotherapy | Experimental | ONO-4578 specified dose on specified days in advanced or metastatic solid tumors |
|
| Part B: ONO-4578 in combination with ONO-4538 | Experimental | ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors |
|
| Part C (Expansion Part): ONO-4578 in combination with ONO-4538 | Experimental | ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer |
|
| Part D (Expansion Part): ONO-4578 in combination with ONO-4538 | Experimental | ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4578 | Drug | ONO-4578 specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status) | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration(Cmax) | Up to Cycle 1 (each cycle is 28 days) | |
| Area Under the blood concentration-time Curve(AUC) | Up to Cycle 1 (each cycle is 28 days) | |
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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 Clinical Site 1 | Nagoya | Aichi-ken | Japan | |||
| Aichi Clinical Site 2 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40618725 | Derived | Kawazoe A, Yamaguchi K, Hamaguchi T, Narita Y, Boku S, Oshima T, Hara H, Hamamoto Y, Ishido K, Esaki T, Hosaka H, Yasui H, Koeda K, Nishina T, Tsuji Y, Fukagawa T, Goto M, Oki E, Sugimoto N, Matsuoka H, Yokoyama F, Yoshida T, Yoshida K, Oshima Y, Iwasa S. ONO-4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer. Cancer Sci. 2025 Sep;116(9):2523-2536. doi: 10.1111/cas.70130. Epub 2025 Jul 6. | |
| 36082616 |
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| ONO-4538 | Drug | ONO-4538 specified dose on specified days |
|
| Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538 |
| Up to Cycle 1 (each cycle is 28 days) |
| Toyoake |
| Aichi-ken |
| Japan |
| Chiba Clinical Site 1 | Kashiwa | Chiba | Japan |
| Ehime Clinical Site1 | Matsuyama | Ehime | Japan |
| Gunma Clinical Site 1 | Ōta | Gunma | Japan |
| Hokkaido Clinical Site 1 | Sapporo | Hokkaido | Japan |
| Iwate Clinical Site 1 | Yahaba-cho | Iwate | Japan |
| Kanagawa Clinical Site 2 | Sagamihara | Kanagawa | Japan |
| Kanagawa Clinical Site 1 | Yokohama | Kanagawa | Japan |
| Osaka Clinical Site 2 | Hirakata | Osaka | Japan |
| Osaka Clinical Site 3 | Sakai | Osaka | Japan |
| Osaka Clinical Site 4 | Takatsuki | Osaka | Japan |
| Saitama Clinical Site 2 | Hidaka | Saitama | Japan |
| Saitama Clinical Site 1 | Ina-machi | Saitama | Japan |
| Shizuoka Clinical Site 1 | Nagaizumi-Cho | Shizuoka | Japan |
| Tokyo Clinical Site 1 | Chuo-ku | Tokyo | Japan |
| Tokyo Clinical Site 4 | Itabashi-ku | Tokyo | Japan |
| Tokyo Clinical Site 2 | Koto-ku | Tokyo | Japan |
| Tokyo Clinical Site 3 | Shinjyuku-ku | Tokyo | Japan |
| Fukuoka Clinical Site 1 | Fukuoka | Japan |
| Fukuoka Clinical Site 2 | Fukuoka | Japan |
| Osaka Clinical Site 1 | Osaka | Japan |
| Derived |
| Iwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E2 receptor 4, alone and with nivolumab in solid tumors. Cancer Sci. 2023 Jan;114(1):211-220. doi: 10.1111/cas.15574. Epub 2022 Nov 4. |
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| 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 |
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