This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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.
2. Participants who are refractory or intolerant to standard therapy.
3. 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.
4. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1.
5. Participants with tumor tissue samples available for biomarker testing.
Exclusion Criteria:
1. Participants with a complication or history of severe hypersensitivity to any other antibody drugs.
2. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
3. Participants with severe peritoneal dissemination.
4. Participants with pericardial fluid, pleural effusion, or ascites requiring treatment.
5. Participants with uncontrolled tumor-related pain.
6. Participants with active or history of interstitial lung disease or pulmonary fibrosis.
Primary outcome measure(s)
Dose-limiting toxicities(DLT) — 21 days
Adverse event (AE) — Up to 2 years
Trial sites (15)
Facility
City
Region
Status
Nagoya University Hospital
Nagoya
Aichi-ken
National Cancer Center Hospital East
Kashiwa
Chiba
Kurume University Hospital
Kurume
Fukuoka
Hyogo Medical University Hospital
Nishinomiya
Hyōgo
Kitasato University Hospital
Sagamihara
Kanagawa
Kanagawa Cancer Center
Yokohama
Kanagawa
Kochi Medical School Hospital
Nankoku
Kochi
Kyoto University Hospital
Kyoto
Kyoto
Kansai Medical University Hospital
Hirakata
Osaka
Osaka International Cancer Institute
Osaka
Osaka
Kindai University Hospital
Sakai
Osaka
Saitama Medical University International Medical Center
Hidaka
Saitama
Saitama Cancer Center
Shinden
Saitama
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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