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This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-7428 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-7428 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities(DLT) | 21 days | |
| Adverse event (AE) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Up to 2 years | |
| Tmax | Up to 2 years | |
| Area under the Plasma Concentration versus Time Curve (AUC) |
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Inclusion Criteria:
Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors.
[Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification.
Participants who are refractory or intolerant to standard therapy.
Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen.
Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
Participants with tumor tissue samples available for biomarker testing.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| North America Clinical Trial Support Desk | Contact | +18665877745(Toll-Free) | clinical_trial@ono-pharma.com | |
| International Clinical Trial Support Desk | Contact | +17162141777(Standard) | clinical_trial@ono-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya University Hospital | Recruiting | Nagoya | Aichi-ken | Japan | ||
| National Cancer Center Hospital East |
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| Up to 2 years |
| Ctrough | Up to 2 years |
| Objective Response Rate (ORR) | Up to 2 years |
| Disease Control Rate (DCR) | Up to 2 years |
| Overall Survival (OS) | Up to 2 years |
| Progression-Free Survival (PFS) | Up to 2 years |
| Duration of Response (DOR) | Up to 2 years |
| Time to Response (TTR) | Up to 2 years |
| Best Overall Response (BOR) | Up to 2 years |
| Percent change from baseline in the sum of diameters of target lesions | Up to 2 years |
| Best reduction percent change from baseline in the sum of diameters of target lesions | Up to 2 years |
| Recruiting |
| Kashiwa |
| Chiba |
| Japan |
| Kurume University Hospital | Recruiting | Kurume | Fukuoka | Japan |
| Hyogo Medical University Hospital | Recruiting | Nishinomiya | Hyōgo | Japan |
| Kitasato University Hospital | Recruiting | Sagamihara | Kanagawa | Japan |
| Kanagawa Cancer Center | Recruiting | Yokohama | Kanagawa | Japan |
| Kochi Medical School Hospital | Recruiting | Nankoku | Kochi | Japan |
| Kyoto University Hospital | Recruiting | Kyoto | Kyoto | Japan |
| Kansai Medical University Hospital | Recruiting | Hirakata | Osaka | Japan |
| Osaka International Cancer Institute | Recruiting | Osaka | Osaka | Japan |
| Kindai University Hospital | Recruiting | Sakai | Osaka | Japan |
| Saitama Medical University International Medical Center | Recruiting | Hidaka | Saitama | Japan |
| Saitama Cancer Center | Recruiting | Shinden | Saitama | Japan |
| Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Recruiting | Bunkyō-Ku | Tokyo | Japan |
| The Cancer Institute Hospital Of JFCR | Recruiting | Koto-Ku | Tokyo | Japan |